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.

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

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.

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.
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.

Nectotizing Enterocolitis Surgery Trial (NEST)

Purpose of study:

Previous studies suggest that the type of procedure performed for perforated necrotizing enterocolitis does not influence survival. However, long-term neurodevelopmental outcomes of these babies has not been determined. The purpose of the current study is to determine whether the initial type of surgical procedure performed for perforated necrotizing enterocolitis influences the long-term neurodevelopmental outcome of these babies.

Who can participate: 

Newborn babies in the Neonatal Intensive Care Unit with necrotizing enterocolitis and intestinal perforation.

What will happen during the study: 

Babies with necrotizing enterocolitis and intestinal perforation will be randomized to receive either exploratory laparotomy of peritoneal drainage as their initial surgical procedure. Neurodevelopmental outcome will be followed in these bables throughout the first 2 years of life.

Who to contact: 

Dr. Gail Besner, 614-722-3900
Dr. Leif Nelin, 614-722-2775
Christine Fortney, 614-722-6489 or
Christine.Fortney@nationwidechildrens.org 

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