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.
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
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
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
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
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/
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
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
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
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
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
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
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/.
Nearly a half-million infants are born prematurely in the US (15 million worldwide). Most suffer from abnormal brain maturation resulting from how the immature brain interacts with atypical sensory experiences after birth. The MIND study (Mother’s Voice Interventions with Infants at Risk for Neurodevelopmental Disorders) uses a parent-supported multisensory intervention that uses an FDA approved pacifier-activated device to play a parents' voice in response to infant suck on a pacifier, while a therapist holds the infant and provides supportive containment. We are measuring the effects of the intervention and determining mechanisms that improve brain multisensory processing, reactions to sensory stimulation after the infant goes home, and long-term language and motor development to help optimize future intervention designs. Our goal is to implement the intervention in multiple neonatal care settings where parents cannot continuously be present at their child's bedside.
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
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
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
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
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
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. Carl Backes
Carl.Backes@NationwideChildrens.org
Kristi Small, (614) 355-6649
Kristi.Small@NationwideChildrens.org
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
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