Neonatology Clinical Research

Research efforts at Nationwide Children's Hospital’s Section of Neonatal Medicine are focused on making advances in the prevention, diagnosis and treatment of premature infants, as well as the prevention of complications of preterm birth.

To see current research studies related to Neonatology being conducted at Nationwide Children's Hospital, search the options below.

Antimicrobial Stewardship

Purpose of study: 

This study seeks to assess antibiotic use among infants in the NICU that will lead to targeted interventions that will result in a significant reduction in overall antibiotic usage in these high risk infants.

Who can participate: 

This study will review all medical charts of NICU patients starting from January 1st 2014 and onward.

What will happen during the study: 

Data from the medical record relating to clinical care of infants admitted to the NICU will be analyzed.  This includes but may not be limited to dates (e.g. of admission, disharge/death, therapies, lab sample collection), maternal history, medication dosages, microbiology lab results, clinical impressions, birth histories, procedures.

Who to contact:   

Dr. Pablo Sanchez, PI

Cory Hanlon, Study Coordindator:  (614)355-6636, or Cory.Hanlon@NationwideChildrens.org

APPLES Research Study: A Soft Constraint Parent-Directed Therapy for Infants and Toddlers 9-27 Months

What is the purpose of this study?

The purpose of this study is to evaluate the effectiveness of a soft mitt constraint on a weaker hand and parent-directed interactions on arm function for young children with hemiplegic cerebral palsy (CP).

Infants and young toddlers in this study will use a non-invasive, soft mitt for Constraint Induced Movement Therapy (CIMT), a therapy that is well-tested in older children with CP, along with specific games and activities.

Image: APPLES Study constraint participant crawling in a session with Helen Carey, PT, DHSc, PCS

  • Some of the participants in this study will have CP, while others will not have motor difficulties.

  • The study team will test how well a soft mitt used on the more affected hand, along with therapeutic activities taught by physicial therapists (from Nationwide Children's Hospital and The Ohio State University) may help improve motor function for participants with CP.

  • Children enrolled in this study that do not have CP will only participate in assessment visits and will not use the soft mitt.

Who can participate in this study?

Infants and toddlers between the ages of 9-27 months at the time of enrollment are eligible for this study, after signed parental consent has been completed.

  • Ages 9 to 27 months at the start of the study

  • Infants with cerebral palsy who have one side of their body stronger than the other

  • Infants without cerebral palsy and no other motor difficulties to participate as controls

Caregivers must be willing to have their child with cerebral palsy wear a soft mitt for six (6) hours at a time and provide two (2) daily at-home sessions lasting 15 minutes each. After the mitt is taken off, caregivers will need to play with their child using two-handed toys as much as possible. Training and support by therapists, as well as materials for activities, will be provided to caregivers.

Caregivers must also be willing to come to Nationwide Children's Hospital for assessments, and transportation will be arranged as needed.

What will happen during this study?

There will be several visits during this study:

  • Participants with cerebral palsy will have assessment and training visits.

  • Participants without motor difficulties will only have assessment visits.

Assessment appointments will take between 45-60 minutes. During the appointment, research therapists will assess your child using standard movement assessments. A test called "Event-Related Potential (ERP)" will also be performed to measure natural brain electricity and record your infant's brain waves, using soft sensors placed on your child's head with a net, like a shower cap.

At the end of the first assessment visit, therapists will teach caregivers of participants with CP how to do activities at home using the mitts and supplies that we provide.

This study is randomized. This means that young infants and toddlers with CP will be randomly assigned to one of two groups:

  • For children with CP, participants in both groups will receive the soft mitt constraint intervention.

  • The difference between the two groups will be the timing of the start of these additional therapy services.

    • Your child will continue their regular therapy visits regardless of his/her group study assignment and regardless of his/her participation in the study.

    • In addition to providing materials to caregivers, we will also compensate you for your time.

Who can I contact for more information?

Please contact the APPLES study team, led by Nathalie Maitre, MD, PhD, by phone at (614) 935-6626 or by email at ApplesStudyGroup@NationwideChildrens.org.

Baby CHAMP Study: Therapy Trial for Infants and Toddlers with Hemiparetic Cerebral Palsy

What is the purpose of this study?

The Frequency: Dosing for Rehabilitation Delivery in Children with Cerebral Palsy study, also known as the Baby CHAMP Study, is a clinical trial to compare three highly promising forms of therapy for infants and toddlers who have a diagonsis of hemiparetic cerebral palsy. The therapy is designed to increase the child’s skills and everyday use of the impaired (weaker) upper extremity. 

Who can participate in this study?

Infants and toddlers are eligible to participate if their parents provide signed permissions and if they meet the following conditions:

  • 6-24 months old at the time the therapy will start

  • Have a medical diagnosis of cerebral palsy (CP)

  • Have significant impairment in the use of one of their upper extremeties (arm and hand) - this is often labeled hemiparesis or asymmetrical CP

  • Can communicate their basic needs and are able to interact in a playful way with a familiar adult, such as their parent or a therapist

  • Have one or both parents who are willing to participate in learning how to provide at-home therapy activities that will involve about 45 minutes per day over a four-week period (described in more detail below)

What will happen during this study?

First, we will ask you to provide us with a copy of your child's medical record and your child's MRI scans, which you can obtain from your physician and share with us. We will ask that you do this when you enroll in the study and then again 12 months after treatment.

Because part of this study involves your participating in therapy, we will also ask you to participate in a 2-3 training about ACQUIRE and how to use these approaches safely and effectively with your child. There are three types of therapies:

  • Condition 1 is named ACQUIRE with casting - this therapy condition involves your child having a lightweight, semi-flexible cast molded for his or her "stronger arm."

  • Condition 2 is named ACQUIRE with part-time splint - this therapy condition involves your child wearing a splint that covers just part of the "stronger arm" (from the mid-arm through the fingers).

  • Condition 3 is named ACQUIRE for both arms - this therapy condition is identical to the two conditions above, except that your child does not wear any constraint on the "stronger arm" during therapy or in non-therapy time.

As part of the therapy, for three hours each day and five days each week, an ACQUIRE therapist will provide therapy that focuses on the therapy goals that you and your therapist select as important for your child. Each day of the week, you will also provide an additional 45 minutes of practice for your child. 

The therapy will occur in your home (or a natural environment, such as grandparents' home or other caregiver's home) during the month-long period of therapy. At the end of the four weeks, the therapist will develop with you a plan for post-treatment activities.

Who can I contact for more information?

For more details, please contact Christopher Brown at (614) 688-2081 or Christopher.Brown@OSUMC.edu or contact Dr. Amy Darragh at Amy.Darragh@OSUMC.edu.

Body Composition in High Risk Neonates

Purpose of study:

To determine the association between body adiposity and infant dysphagia, and how this effect is modulated by ARH levels. We hypothesize that higher body adiposity is associated with early satiety and reduced hunger, and these effects are modulated by ARH levels such as leptin (satiety hormone) and ghrelin (hunger hormone).

Who can participate:

Infants between 38 and 50 weeks PMA with feeding difficulties, clinically stable and on room air, tolerating full enteral feeds.

What will happen during the study:

The body composition of eligible infants will be measured using the PEAPOD and body composition parameters will be recorded. Blood specimen for leptin and ghrelin will be obtained along with the routine NICU labs/weekly growth labs, so infants will not be subject to additional needle sticks.

Who to contact:

Dr. Sudarshan Jadcherla, PI

Rebecca Moore, RN Coordinator: (614) 655-6635

CMV and NEC

Purpose of study: 

This study, by examining intestinal tissue for presence of CMV by molecular methodologies like Polymerase Chain Reaction (PCR) testing and 16S ribosomal testing, will determine the frequency of CMV infection in infants with NEC or SIP. Given that CMV infection can be treated with antiviral medication, this study may lead to prompt identification and treatment of infants with these conditions and thus improve outcomes. 

Who can participate: 

Any infants receiving surgery related to NEC or SIP can participate in this study.

What will happen during the study:

All infants who had surgery for NEC or SIP and had intestinal tissue sent to pathology as standard care, as well as infants who died with NEC/SIP and had an autopsy performed will be identified and the intestinal tissue tested for CMV by immunohistochemistry and PCR. Their medical records will be reviewed for pertinent demographic, clinical, laboratory, radiographic and outcome data. 

Who to contact: 

Dr. Pablo Sanchez, PI

Santiago Panesso, Study Coordinator: (614) 722-2735, or Santiago.Panesso@NationwideChildrens.org

Congenital Diaphragmatic Hernia Registry

What is the purpose of this study?

The purpose of this registry and the CDH Study Group is to collect and analyze information on congenital diaphragmatic hernia (CDH) with the hope that with careful delineation of the natural history of this disease that appropriate interventions can eventually be identified. By developing this anonymous, comprehensive database, it is hoped that the natural history of the disease and its treatment can be clearly defined.

This is a multicenter/multinational, prospective observational registry of children born with CDH from 90 centers represented by 10 countries around the world.

Who can participate in this study?

All infants with CDH admitted to Nationwide Children’s Hospital.  The plan is to continue to enroll new infants indefinitely.  Data is collected from the infant’s hospital chart/record.

How can I get more information or participate?

Dr. Leif Nelin, Leif.Nelin@NationwideChildrens.org

Rox Ann Sullivan, RN, Roxann.Sullivan@NationwideChildrens.org

Darbe

Purpose of study:

Preterm birth (when a baby is born before 37 weeks of pregnacy) affects about 1 of every 10 babies born in the United States. Not all babies born this early survive, and some who do survive may develop serious medical problems related to the brain and other organs because they have not had time to develop in the last few weeks of pregnancy. The purpose of this study is to see if a medicine called Darbepoetin (Darbe), when given to babies born prematurely, can help with brain growth and protect the brain.

This study is part of the Neonatal Research Network and 15 sites across the nation are participating in it. This study is being done by Dr. Omid Fathi at the NICUs at Nationwide Children’s Hospital, the Wexner Medical Center at OSU, and Riverside Methodist Hospital. Overall, 650 participants will take part in this study.

Who can participate:

Babies born at 23 to 28 weeks and who are less than 24 hours old can participate in this study.

What will happen during the study:

Infants will be randomized to one of two groups: treatment or control. The treatment group will receive Darbe and the control group will receive placebo, a sugar solution.  Infants will receive study medication once a week for up to 13 weeks (13 doses). Parents will be asked to bring their child to one follow up visit at 2 years of age to access neurodevelopmental outcomes.

Who to contact:

Dr. Pablo Sanchez, PI: Pablo.Sanchez@NationwideChildrens.org

Patty Luzader, RN Lead Clinical Research Coordinator: (614) 355-6627

More information about the study can be found at: https://neonatal.rti.org/

Early Prediction Study

Overview:

The Early Prediction study is a follow-up study to the Perinatal Brain Injury Magnetic Resonance Imaging (PBI-MRI) study. We are trying to understand what causes brain injury and abnormal brain development in premature infants. We also are hoping to find a way using advanced MRI (Magnetic Resonance Imaging) to predict problems that premature infants will have so that we can help them develop better.

In the Early Prediction Study, we will be doing an advanced MRI at the age the preterm infant would have been born at if carried to term. We will then follow the infant’s development until at least the age of three years old. In addition, we will be enrolling some healthy, full term infants as control subjects.  

All MRI results are shared with the family as well as the infant’s doctors.

Study Updates:
As of September 2015: We have enrolled and completed MRIs for 65 healthy control infants, as well as 80 preterm infants in our study so far. Our plan is to enroll 272 preterm infants who were born at less than 32 weeks of gestational age, as well as 80 healthy term infants for comparison, from four local hospitals. We appreciate all the families who have allowed their infants to participate in this study!

Contact Information:
Please contact Jennifer Notestine at Jennifer.Notestine2@NationwideChildrens.org or 614-355-6634 for more information.

Frequently Asked Questions:

  • I am interested in the study - how do I sign up?
    If you have a newborn who is either a preterm infant born less than 32 weeks gestational age, or a healthy term newborn, and you are interested in participating, contact Jennifer Notestine at 614-355-6634 or Jennifer.Notestine@NationwideChildrens.org. She would be happy to explain the study to you and answer any questions you may have about participation.
     
  • I want to do the study, but I’m not at the hospital. Can I give consent by phone?
    We are unable to obtain consent for this study over the phone. However, Jennifer can explain the study to you and answer any questions you may have. If you would like to participate in the study, you can complete the consent before the imaging is done.
  • MRIs are loud- what do you do to protect the baby from noise?
    We do several things to help shield the infant from noise. We use silicone ear putty secured in the ear. We also cover the ears with padding to further cut down on noise during the scanning process.
     
  • How do you ensure the infants are safe during the MRI?
    A study nurse (who is an experienced NICU nurse) will accompany your baby during the scan - your baby is monitored for heart rate and pulse oximeter during the MRI. If your child is still using oxygen a doctor involved with the study will also be present during the MRI.
     
  • Are parents allowed to be present in the MRI?
    Parents do not go into the MRI scanner area because of safety reasons. However, they are welcome to stay in a nearby waiting room. Study staff will update parents periodically on how the infant is doing.
     
  • Is the baby being exposed to radiation during MRI?
    No - the MRI testing uses a giant magnet. The MRI does not use radiation, and it is safe for infants.
     
  • What if my baby does not hold still during the MRI?
    Study staff will swaddle the infant and give the infant a pacifier if needed. Infants will be fed and diaper changed if needed before the testing to help the infant be still. Study staff will help the infant to fall into natural sleep for scanning. If the infant wakes, pacifier and soothing is offered. The infant may be given a small amount formula, if thought that he/she is hungry. If the infant still will not sleep for scan after attempts made, the scan will be cancelled. This is not a common occurrence.
     
  • Will you give my baby medicine to make him/her sleep during the MRI?
    We do not give any sedation or medication to make the infant sleep. We attempt to help the infant fall asleep naturally.
     
  • How long does the MRI take?
    Generally, the MRI takes between 45 minutes up to 1 ½ hours to complete, depending on how well the infant sleeps during the testing.
     
  • Who can I contact with questions about the study?
    You can call Jennifer Notestine at (614) 355-6634.
Effect of Parenteral Nutrition on Body Composition

Purpose of study:

To determine if the composition and duration of parenteral nutrition (TPN) has an effect on body composition.

Who can participate:

Hospitalized infants born at greater than or equal to 34 weeks gestational age who required at least 2 weeks of TPN.

What will happen during the study:

Infants who meet the inclusion criteria will under go measurments in the PeaPod  and skinfold thickness tests weekly until discharge.

Who to contact:

Dr. Sudarshan Jadcherla, PI

Rebecca Moore, RN Coordinator: (614) 655-6635

Exo NEC

Purpose of study:

Babies born at or before 34 weeks of gestational age are at risk for developing a disease called Necrotizing Enterocolitis (NEC). This is a devastating disease in premature infants in which the intestines become severely injured. The mortality rate is as high as 50% in very premature babies. At this time there is no known way to prevent NEC. This study aims to identify differences in components of the blood and urine that can be used to better diagnose and treat NEC in order to prevent babies from getting NEC in the future.

This study is being conducted by Dr. Gail Besner at Nationwide Children’s Hospital. Overall, 40 participants will take part in this study.

Who can participate:

Babies born at or before 34 weeks and are more than 72 hours old can participate in the study. Babies will be enrolled if they are evaluated for NEC, sepsis (infection) or are an age matched control (healthy).

What will happen during the study:

Urine and blood samples will be collected at three different time points. All study-related blood samples will only be obtained when blood is drawn as part of routine care.
 

Who to contact:

Dr. Gail Besner, PI: Gail.Besner@NationwideChildrens.org

Dr. Courtney Pisano: (614) 355-2830

Gan Preemie

Purpose of study: 

The goals of the study are to determine ganciclovir pharmacokinetic and pharmacodynamic parameters in premature infants who receive IV ganciclovir as part of medical care to treat cytomegalovirus infections.

Who can participate: 

Infants born at less than 32 weeks gestational age with a confirmed congenital cytomegalovirus infection that is being treated with IV ganciclovir are eligible for participation.

What will happen during the study: 

This study will last 6 weeks and will be further broken up into 7 periods of sample collection.  During each collection period, urine and blood will be taken to determine the amount of virus in the infant.  During the 1st period, the blood for the pharmacokinetics will be drawn.  This will involve blood being drawn 5 additional times over a set 12 hour period.

Who to contact: 

Dr. Pablo Sanchez, PI

Cory Hanlon, Study Coordinator: (614) 355-6636, or Cory.Hanlon@NationwideChildrens.org

High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL)

Purpose of the study:

This is a study to test whether Erythropoietin (“Epo”) safely reduces the risk of long-term motor and cognitive impairment in infants with hypoxic-ischemic encephalopathy. Epo is a medicine that has been used for decades to treat newborn infants with anemia; however, Epo is considered experimental when given to infants to reduce brain injury.

Who can participate:

Term infants with moderate to severe hypoxic-ischemic encephalopathy receiving active or passive whole body cooling / hypothermia since <6 hours of age.

What will happen during the study:

Infants will be randomized to Epo or placebo 1000/U/kg/dose IV X 5 doses. In addition, 3 blood samples and 2 urine samples will be collected during the first week of life. Neurodevelopmental follow-up will occur until 2 years of age.

Who to contact:

Dr. Nathalie Maitre, PI: Nathalie.maitre@nationwidechildrens.org

Ashley Miller, Therapist: (614) 722-4815 or Ashley.Miller2@NationwideChildrens.org

Infant GERD Management

Purpose of study:

To compare and analyze the short term effects of feeding strategies and the effect of growth and maturation on Gastro-esophageal Reflux.

Who can participate:

Infants who are more than 34 weeks corrected gestational age or full term born with symptoms of GERD and who have a pH/impedance study with an Acid Reflux Index greater than 3.

What will happen during the study:

If an infant is enrolled in the study, an esophageal manometry study will be performed. The infant will be randomized into one of 2 groups. One group will be restricted in the amount of formula they will receive throughout the day, the other group will continue their current feeding regime. Both groups will receive Acid Suppressive Therapy for 4 weeks and then will have a 1 week wash out period. After the wash out period, infants in both groups will have repeat manometry and pH/impedance. If the infant has been discharged to home, we will ask the parents to bring them back to NCH for an overnight stay.

Who to contact:

Dr. Sudarshan Jadcherla, PI

Rebecca Moore, RN Coordinator: (614) 655-6635

Life After Pregnancy Study

What is the purpose of this study?

The Life After Pregnancy Study is a one-time survey study for mothers of babies.

It is a 40-minute survey about the joys and challenges of being a new mother. Participants are asked questions about the birth and feeding of one’s child, one’s physical health and emotional well-being, as well as services one may have received. The research team hopes to learn more about the experiences of new mothers to improve services offered both before and shortly after birth.

Who can participate in this study?

Women are eligible to participate in this study if they:

  1. Are 18 years of age or older and
  2. Have a child between 2 and 6 MONTHS of age.

How can I get more information or participate?

If you are interested in participating in our Life After Pregnancy Study, please click the link below to read about your rights as a research participant and take the survey.

If you have questions about the study, you can reach us at (614) 355-3578 or LAPS@NationwideChildrens.org

Mechanisms and Management of Infant Dysphagia

Purpose of study:

To help understand why some babies have swallowing difficulties and develop better treatment strategies.

Who can participate:

Infants less than 60 weeks PMA who are having Video Swallow Studies and do not have any conditions that would exclude them from participation.

What will happen during the study:

Before going down for the video swallow study, a manometry catheter is placed through the baby's nose and into the esophagus. This catheter stays in place through the video swallow study. After the video swallow study, the catheter will stay in place and we will perform an esophageal manometry study. At the completion of the manometry study, and depending on the VSS results, the parents will be offered the choice of following the recommendations of the VSS team or to opt for a modified flow nipple. A repeat manometry will be performed 4 weeks later.

Who to contact:

Dr. Sudarshan Jadcherla, PI

Rebecca Moore, RN Coordinator: (614) 655-6635

Mechanisms of Infant Dysphagia

Purpose of study:

To help understand why some babies have swallowing difficulties and develop better treatment strategies.

Who can participate:

Infants less than 60 weeks PMA who are having Video Swallow Studies and do not have any conditions that would exclude them from participation.

What will happen during the study:

Before going down for the video swallow study, a manometry catheter is placed through the baby's nose and into the esophagus. This catheter stays in place through the video swallow study. After the video swallow study, the catheter will stay in place and we will perform an esophageal manometry study.  This will only happen once, no repeat studies.

Who to contact:

Dr. Sudarshan Jadcherla, PI

Rebecca Moore, RN Coordinator: (614) 655-6635

Milrinone

Purpose of study:

Congenital Diaphragmatic Hernia (CDH) is a birth defect where there is a hole in the muscle that separates the abdomen from the chest. Contents of the abdomen can go up into the chest through this hole and take up space, preventing the lungs from growing properly.  Small lungs have small blood vessels which may lead to high blood pressure in the lungs and low blood flow to the lungs. One of the main causes of death in infants with CDH is high blood pressure in the lungs.

The purpose of this study is to gather data on whether a drug called Milrinone, when administered to infants with CDH, will help the heart and lungs work better by opening up the blood vessels in the lungs and allowing more oxygen to go to the rest of the body.

This study is part of the Neonatal Research Network and 15 sites across the nation are participating in it. This study is being done by Dr. Ruth Seabrook at Nationwide Children’s Hospital. Overall, 66 participants will take part in this study.

Who can participate:

Infants diagnosed with CDH can participate in this study.

What will happen in the study:

Infants will be randomized to one of two groups: treatment or control. The treatment group will receive Milrinone and the control group will receive placebo, a sugar solution.  Infants will receive study drug for up to 72 hours. Parents will be asked to complete 3 phone surveys once their child is 4, 8, and 12 months old to assess health outcomes.

Who to contact:

Dr. Pablo Sanchez, PI: Pablo.Sanchez@NationwideChildrens.org

Dr. Ruth Seabrook, PI: Ruth.Seabrook@NationwideChildrens.org

Patty Luzader, RN Lead Clinical Research Coordinator: (614) 355-6627

More information about the study can be found at:  https://neonatal.rti.org/.

Mother’s Voice Interventions with Infants at Risk for Neurodevelopmental Disorders

Purpose of the study:

This is a study to find out if sucking on a pacifier and listening to mother’s voice can help with feeding in infants in the NICU who are at risk for motor problems in the future.

Who can participate:

Infants in the NICU with post-menstrual age between 33 and 42 at study start; diagnosis of Grade III/IV IVH, hydrocephalus, PVL, neonatal encephalopathy, or thrombosis/infarct with involvement of the posterior limb of the internal capsule or cramped-synchronized or poor repertoire on the General Movements Assessment (GMA).

What will happen during the study:

The study coordinator will schedule a time to record parent singing a few simple lullabies. Infants will be randomized to 20 sessions of parent’s voice + pacifier or 20 sessions of parent’s voice. The intervention period will last for approximately 2 weeks. Infants will hear their caregiver’s voice recording 1-2 times per day, 15 minutes each time, played through the music player. Follow-up visits in the neurodevelopmental follow-up clinic will be per standard schedule at 3-4 and 9-12 months.

Who to contact:

Dr. Nathalie Maitre, PI: Nathalie.Maitre@NationwideChildrens.org

Ashley Miller, Therapist: (614) 722-4815 or Ashley.Miller2@NationwideChildrens.org

Optimizing the Management of Neonatal Feeding Problem: FQI

Purpose of study:

A NICU wide QI project to determine if focused feeding rounds would make a positive impact on infants reaching feeding milestones in a timely manner and over all length of stay.

Who can participate:

Infants who were born at <32 weeks GA, who are in the NICU and do not meet the exclusion criteria.

What will happen during the study:

Infants will be seen during weekly feeding rounds and feeding milestones, growth characteristics and parent involvement will be recorded.

Who to contact:

Rebecca Moore, RN Coordinator: (614) 655-6635

Pacifier Activated Device-Training with Mother’s Voice in Infants with Complex Congenital Heart Disease

Purpose of the study:

This is a study to find out if non-nutritive suck training using a standard pacifier and reinforcement with mother’s voice can improve the oral feeding outcomes of infants with congenital heart disease.

Who can participate:

Infants in the NICU with a diagnosis of a complex congenital heart defect and scheduled for a surgical intervention. Must meet CTICU feeding guidelines criteria.

What will happen during the study:

The study coordinator will schedule a time to record parent singing a few simple lullabies. Infants will be randomized to either 5 days of parent’s voice + pacifier, surgery, 5 days of parent’s voice OR 5 days of parent’s voice, surgery, 5 days of parent’s voice + pacifier. Infants will hear their caregiver’s voice recording 2 times per day, 15 minutes each time, played through the music player for 5 days before and after surgery. Participants in group 1 will suck on their pacifier while listening to the voice recording during the 5 days before surgery and receive the voice without the pacifier for 5 days after the surgery. Participants in group 2 will have the opposite schedule. A feeding assessment over the phone will be done 1 month post-discharge, and a follow-up visit in the neurodevelopmental follow-up clinic will be per standard schedule at 12 months.

Who to contact:

Dr. Nathalie Maitre, PI: Nathalie.Maitre@NationwideChildrens.org

Lelia Emery: (614) 722-2847 or Lelia.Emery@NationwideChildrens.org

PaTTeN Registry

Purpose of study:

Persistent Pulmonary Hypertension in the Newborn (PPHN) is a life-threatening condition. This happens when the blood vessels in the lungs of newborns do not open enough to allow sufficient blood flow to the lungs. This can ultimately reduce the oxygen sent to the brain and other vital organs. Inhaled nitic oxide (INOMAX) is FDA approved for use as treatment of PPHN in babies born at least 34 weeks. INOMAX is not FDA approved for use in babies born less than 34 weeks and therefore it is at the discretion of the treating physician to use it in these premature babies. The purpose of this retrospective study is to gather data on whether INOMAX is an appropriate treatment of PPHN in babies born before 34 weeks of pregnancy.  

This study is sponsored by Mallinckrodt Pharmaceuticals and is being conducted by Dr. Leif Nelin at Nationwide Children’s Hospital. Overall, 168 participants will take part in this study.

Who can participate:

Babies born between 27 and 40 weeks of pregnancy that received iNO treatment for PPHN can participate in this study.

What will happen during the study:

Retrospective data will be collected to evaluate the use of INOMAX therapy in two groups of babies with PPHN: babies born before 34 weeks and babies born after 34 weeks.

Who to contact:

Dr. Leif Nelin, PI: Leif.Nelin@NationwideChildrens.org

Patty Luzader, RN Lead Clinical Research Coordinator: (614) 355-6627

Perinatal Brain Injury Magnetic Resonance Imaging (PBI-MRI) Study

Overview:

The Perinatal Brain Injury Magnetic Resonance Imaging (PBI-MRI) study is a research study to help improve our understanding of brain development in premature infants. Because brain injury and abnormal brain development are common in premature infants, we want to understand what causes it and what can help make it better. In this study we use MRI (Magnetic Resonance Imaging) as well as EEG (Electroencephalograms) to study the brain at various stages of development. We then follow the infants’ development for 2 years. The information we learn from this study could help us improve the care and outcomes for very preterm infants.

In this study, we use a special infant transporter, called the Nomag to transport infants to MRI. This transporter is a fully functional MRI isolette with full monitoring and treatment capabilities.

Contact Information:

For more information, you can call Jennifer Notestine at (614) 355-6634.

Study Updates for PBI-MRI:

As of October 2014, our enrollment is complete. We only have a few infants who are finishing their final MRI and EEG. Many of our participants have turned a year old, and several have reached two years of age.

We encourage all our participants to continue to attend your developmental assessments - these are important for your child's health and well-being, as well as for our study. We thank all our participant families for being such an integral part of this study. We hope to learn many things that will help premature infants in the future.

Preemie Hypothermia

Purpose of study:

Neonatal Encephalopathy (NE)  is a serious condition that usually occurs when too little blood flows to the brain. There is also too little oxygen delivered to the brain because of this low blood flow. Problems at the time of birth usually cause this. Infants with NE have a high chance of brain injury, long term problems with developmental, and death. Unfortunately, for premature babies who develop NE, there currently is no treatment to prevent or reduce the seriousness of injury to the brain.

Determine whether whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) and ≥1500 grams birth weight is safe and will reduce death or moderate/severe disability at 18-22 months corrected age.

Who can participate:

Infants who are preterm between 33 and 35 weeks at birth.  Less than 6 hours old with moderate to severe NE.  NE was formerly called hypoxic-ischemic encephalopathy (HIE),

What will happen during the study:

Infants will be randomly assigned to either a whole body cooling (33.5˚C) or normothermia (36.5-37.3°C) group.  Hypothermia or whole body cooling will be obtained with a special cooling blanket.  The intervention will last 72 hours.  Monitoring the infant will last until infant goes home.  A two year follow-up visit with a research team member will take place at Nationwide Children’s Hospital.

Who to contact:

Dr. Roopali Bapat, Roopali.Bapat@NationwideChildrens.org

Dr. Pablo Sanchez, Pablo.Sanchez@NationwideChildrens.org

Rox Ann Sullivan, RN, Roxann.Sullivan@NationwideChildrens.org

Remodulin

Purpose of study:

Persistent Pulmonary Hypertension in the Newborn (PPHN) is a life-threatening condition. This happens when the blood vessels in the lungs of newborns do not open enough to allow sufficient blood flow to the lungs. This can ultimately reduce the oxygen sent to the brain and other vital organs. Currently the only approved medicine for treatment of PPHN is inhaled nitric oxide (iNO). The purpose of this study is to see if a medicine called Remodulin, when given to babies with PPHN receiving iNO, can help the heart and lungs work better by keeping the blood vessels to the lungs open so that more oxygen can go to the rest of the body.

This study is sponsored by United Therapeutics and multiple sites across the United States and United Kingdom are participating in it. This study is being done by Dr. Molly Ball at Nationwide Children’s Hospital. Overall, 70 participants will take part in this study.

Who can participate:

Babies receiving iNO treatment for PPHN can participate in this study.

What will happen during the study:

Infants will be randomized to one of two groups: treatment or control. The treatment group will receive Remodulin and the control group will receive placebo, a sugar solution.  Infants will receive study medication for up to 28 days.

Who to contact:

Dr. Molly Ball, PI: Molly.Ball@NationwideChildrens.org

Patty Luzader, RN Lead Clinical Research Coordinator: (614) 355-6627

ClinicalTrials.gov Identifier: NCT02261883

Stamina

Purpose of study:

Babies born prematurely (born before 37 weeks of pregnancy) often have times of low oxygen in their blood and need extra oxygen to get back to normal oxygen levels. Nurses and respiratory therapists adjust the amount of oxygen given to babies to prevent too much or too little oxygen.  However, nurses and respiratory therapists cannot be at the baby's bedside all the time, therefore timely adjustment of the delivered oxygen to individual needs is not always possible. This research study will involve the use of new equipment, the AVEA ventilator with the CLiO2 system that will automatically make the oxygen adjustments based on individual needs. This study will compare the oxygen adjustments made by nurses and respiratory therapists and the adjustments made by the AVEA ventilator with the CLiO2 system.  This equipment has been available and marketed in Europe and internationally for over 3 years.   The study is intended to collect the information needed to seek Food and Drug Administration (FDA) approval this equipment in the United States.

This study is sponsored by CareFusion and multiple sites across the United States are participating in it. Dr. Leif Nelin is the site Principal Investigator at Nationwide Children’s Hospital. Overall, 100 participants will take part in this study.

Who can participate:

Babies born between 23 and 33 weeks and receiving supplemental oxygen can participate in this study.

What will happen during the study:

Babies will be transitioned to the AVEA ventilator with the CLiO2 feature. Babies will then be monitored for two consecutive study periods of 24 hours each.  In one study period, the oxygen levels will be adjusted manually by nurses and respiratory therapists, as is normally done in the nursery. In another study period (the experimental period) oxygen levels will be adjusted by the automatic function of the AVEA ventilator.

Who to contact:

Dr. Leif Nelin, PI:  Leif.Nelin@NationwideChildrens.org

Patty Luzader, RN Lead Clinical Research Coordinator: (614) 355-6627

ClinicalTrials.gov Identifier: NCT02716155

The Follow Up of High Risk Infants

Purpose of study:

Babies that are born at less than 27 weeks’ gestation and with very low birth weight are at higher risk for disabilities and death than infants born closer to term gestation and with higher birth weight. Follow up of these premature infants has been shown to be helpful for both these children and their families. To assess the outcomes of babies born before 27 weeks’ gestation and look at ways that we can improve their outcomes, this study aims to enroll these high risk babies in a multicenter study where we can document how they are doing at about 2 years of age. At this 2 year age mark, the infant will be evaluated during routine health assessments to track the health and development of the infant, and to make sure you and your child are receiving the appropriate supportive services and interventions.               

Who can participate:

Infants that have been born [at OSU, RMH, or that have been enrolled into an interventional study at Nationwide Children’s Hospital’s Neonatal Intensive Care Unit] at less than 27 weeks’ gestation.

What will happen during the study:

This study is strictly data-collection. We will not collect samples from your child or give your child a medication or intervention of any sort for the purposes of this research study. All of your child’s medical history will be protected, and your child will be known as a study number for the purposes of the study. We will follow up with you and your child during your regularly scheduled clinic appointments where we will administer questionnaires and later collect data from their medical chart.   

Who to contact:

Dr. Nathalie Maitre, (614) 355-6739
Nathalie.Maitre@NationwideChildrens.org

Kristi Small, (614) 355-6649
Kristi.Small@NationwideChildrens.org

The Impact of Human Milk Oligosaccharide 2’-Fucosyllactose on Growth, Feeding Progression and Neurodevelopment in Preterm Infants

Purpose of study:

This study seeks to better understand and find out whether there is a positive influence on feeding progression and tolerance,  growth, and neurobehavioral changes associated with 2’-FL, as well as other metagenomic or metabolomic associations.

2’-FL  is the most abundant sugar in human milk oligosaccharide, (HMO),  it is found in the milk of most mothers.  Clinical and preclinical evidence suggests that 2’FL, may convey a variety of health benefits.  

Who can participate:

Infants born 29-32 weeks gestational age who will be receiving human milk as their diet, who receive care in the Neonatal Intensive Care Unit (NICU) at Nationwide Children’s Hospital (NCH) main campus or The Ohio State University Medical Center (OSUMC).

What happens during the study:

This is a randomized, controlled trial of 2’-FL.   given as a supplement to infants. meaning an infant will be randomly assigned to receive the study supplement or dextrose.  The Infant will receive either 2’-FL or dextrose, given by mouth twice daily from about the 9th day of life through 45 days after starting the supplement or on the day of discharge from  the NICU.

Who to contact:

Dr. Ethan Mezoff, Ethan.Mezoff@NationwideChildrens.org

Rox Ann Sullivan, RN, Roxann.Sullivan@NationwideChildrens.org

The Seattle-PAP Study

Purpose of Study:

The Seattle-PAP study is a study to find out if a new device can help some babies born early (pre-term) breathe easier.  Once born, most pre-term infants need some help with breathing. Some infants need a machine known as a ventilator forcing air down a tube that is placed in the infant’s windpipe (intubation).  Once a baby is able to breathe on their own, often a different form of breathing help is used called Continuous Positive Airway Pressure, or more simply, CPAP.  CPAP delivers constant air pressure into a baby’s nose to help keep the air sacs in the lungs open and to give oxygen to the baby.  Our study compares two different methods of CPAP delivery: the standard method and a modified method developed at the Seattle Children’s Hospital (Seattle-PAP). The Seattle-PAP  modification is a simple modification of the angle of tubing used to go into the water and the CPAP bubbler itself. The Seattle-PAP method was designed to help premature infants breathe easier to allow the lungs and the muscles enough time to get stronger and reduce the need to place premature infants on ventilator support.

Who can participate:

Infants born at less than 30 weeks gestation and admitted to a participating NICU. 

What will happen during the study: 

Infants are randomized to either the standard CPAP method (Fisher-Paykel) or the modified method (Seattle-PAP) once they are ready to be on CPAP.  Parents are asked to complete a 1-page questionnaire and a consent form.  Study staff will monitor infant while in the study by reviewing the medical record.  All medical decisions about respiratory treatment of the infant are made by the medical team, not the research team.

Who to contact:

Jennifer Notestine 614-355-6695 or Jennifer.Notestine@NationwideChildrens.org

Vocal Cord Injury in Preterms (VIP): A Pilot Cohort Study

Purpose of study:

Treatments to close a patent ductus arteriosus (PDA) are medications such as indomethacin or surgical ligation (tying off).  Sometimes, the nerve that controls the vocal cords is damaged during PDA surgery. As an infant grows older this could result in problems with breathing, feeding, and speech. 

This study is being done to find out how many babies develop problems after PDA surgery because of vocal cord injury (VCI).

Who can participate:

Infants less than 29 weeks at birth who have a PDA ligation. 

What will happen during the study:

After your infants’ PDA surgery, an examination called flexible nasal laryngoscopy will be done at the bedside by an ear, nose, and throat (ENT) doctor. During the laryngoscopy, a thin, spaghetti-like device with a camera will be passed through your child’s nose and into the back of the throat. This will let the study doctor look and see whether or not the vocal cords move normally as your baby breathes. Laryngoscopy is the regular way that ENT doctors look at vocal cords in both children and adults.  The examination will take place within 14 days of the breathing tube being removed.

Your baby will have regular appointments at the neonatal follow-up clinic until they are about 2- years-old. At their 2-year visit, one additional test will be done called the Pediatric Voice Handicap Index (pVHI). This is a question sheet for parents to fill out.   

Who to contact:

Dr. Leif Nelin, Leif.Nelin@NationwideChildrens.org

Rox Ann Sullivan, RN, Roxann.Sullivan@NationwideChildrens.org

VTAP-BPD

Purpose of study

This study aims to look at the types of viruses that premature infants in the NICU are exposed to.  We hope to look at how the body responds to having a virus and if these viruses result in the infant developing BPD or NEC.

Who can participate

Any infant that is born at 32 weeks gestational age or less and is free from any congenital anomalies is able to participate.

What will happen during the study: 

During the study there will be 3 sample collection windows.  These windows are within the first 72 hours of life, 28 days of life, and 36 weeks post menstrual age.  During the collection period, the infant will have several different samples taken during their standard nursing hours of care.  The samples include a cheek swab, nasal swab, stool sample, and perianal sample.  Blood will also be collected during these windows but only when the infant is having blood drawn for clinical tests, no extra sticks will be done for research.

Who to contact: 

Dr. Mohannad Moallem, PI

Cory Hanlon, Study Coordinator: (614) 355-6636 or, Cory.Hanlon@NationwideChildrens.org

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