Research and Scholarly Activities for the Neonatology-Perinatology Fellowship Program

Trainees interested in research are free to participate in an ongoing project, either within the Division or outside the Division, or design a project that is in concert with their interests and career goals.

University of North Carolina

NICHD Neonatal Network

We partner with Duke (Durham) and WakeMed Hospital (Raleigh) to participate in the NICHD Neonatal Network. This consortium of research centers maintains a detailed patient database and designs and implements clinical studies.

Sample Network Studeis

Generic Database (GDB) – The Generic Data Base Study (GDB): Survey of Morbidity and Mortality in High Risk Preterm Infants: Includes data from 16 participating NICHD Network centers on infants less than 29 weeks gestational age (401 grams to 1000 grams) for the purpose of providing data on risk factors for neonatal morbidities and consequences of neonatal disease.

GDB Follow Up Study: Assesses infants born at less than 27 weeks gestational age 18-22 months adjusted age in terms of motor, cognitive and language skills, behavior, growth, neurodevelopmental outcome, mortality and prevalence of medical morbidities, family stress, compliance with medical and developmental care, utilization of special support services and early intervention programs, and need for follow up to school age.

Premature Infant Cooling Study: Infants between 33 and 356/7 weeks gestational age and ≥1500 grams birth weight who present at

NEST: A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for Extremely Low Birth Weight (ELBW) Infants with Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 months Adjusted Age: Study assessing whether the initial surgical treatment of ELBW infants who have NEC or IP should be a laparotomy or percutaneous drain.

MILK Study: This study will compare neurodevelopmental outcomes in infants born at

Hydrocortisone for Bronchopulmonary Dysplasia: The purpose of this trial to study the efficacy and safety of a 10‐day tapering course of hydrocortisone treatment for infants 7days.

Hydrocortisone for Cardiovascular Insufficiency: Hydrocortisone treatment of cardiovascular insufficiency in term and late preterm infants will evaluate the effects of a 7-day course of hydrocortisone on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in infants > 34 weeks gestational age diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

Transfusion of Prematures (TOP) Trial: The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in survival and neurodevelopmental outcome at 22-26 months. Enrolled babies will be randomized to a high or low hematocrit/hemoglobin threshold for transfusion. The assigned threshold is to be used until the baby reaches 36 weeks gestation or is discharged, whichever occurs first.

Incubator Weaning of Moderately Preterm Infants will determine whether the length of hospital stay will be decreased among preterm infants born at 29-33 weeks gestational age weaned from an incubator to an open crib at a lower versus higher weight, (1600g vs. 1800g.).

Other Studies

ELGAN follow-up study: A multi-center, epidemiology-based study of 1600 infants born at

Pharmacokinetics of Sildenafil in Premature Infants: The primary objective of this study is to determine pharmacokinetics of sildenafil in premature infants. Enrolled babies who are receiving sildenafil as a component of their clinical care and were born ≤ 28 weeks gestational age will have 4-5 blood samples to be drawn.

Effect of Feedings on Caffeine Pharmacokinetics and Metabolism in Premature Infants: The purpose of the study is to evaluate the difference in caffeine pharmacokinetics (PK) and metabolism in premature infants fed formula and premature infants fed exclusively breast milk. Infants

SCAMP study will evaluate the safety of 3 therapeutic regimens in premature infants and 1 therapeutic regimen in late preterm and term infants with complicated intra-abdominal infections. Babies with a suspected or confirmed infection who are having CSF obtained clinically, can be enrolled into a 5th group.These babies would receive study drug prior to the CSF sampling.

POPS study: Pharmacokinetics, pharmacodynamics, influence of genetic factors, metabolic and protein profiles on therapeutic of specific understudied drugs which are being administered per standard of care will be studied. Babies receiving a drug of interest and enrolled in the study will have PK samples obtained at the time of clinical blood sampling.

Placental Blood Sampling to Reduce Blood Loss and Blood Transfusions in Premature Newborns will examine a change in practice to reduce early blood loss and anemia in premature infants using placental blood sampling after birth. The primary goal of this study is to decrease early blood loss and blood transfusions in very premature newborns. Blood culture and CBC results of placental blood will be compared with any routine admission blood culture and CBC results.

SOLVE GA (Smartphone Ophthalmoscope Lens Vascularity Estimated Gestational Age): The primary aim of this study is to establish the validity of smartphone ophthalmoscope anterior lens capsule vascularity (ALCV) gestational age estimates among preterm neonates at delivery compared to the referent standard of ultrasound gestational age.

Molecular mechanisms associated with immune development in infants: This study will examine immune development in pre-and full-term infants (specifically myeloid dendritic cell maturation) and test the hypothesis that TLR expression and TLR signaling increase with age by defining CD4+T cell development up to 1 year of age.

The Perinatal Quality Care Collaborative of North Carolina (PQCNC): The PQCNC is a statewide network of the stakeholders in perinatal care all committed to spreading high value care practices. PQCNC’s goal is to make the best possible care available to infants and their mothers, promoting health in an economical and family-centered manner.PQCNC will facilitate and sponsor perinatal improvement projects using the state as a laboratory for planned quality experimentation.

International Research/Implementation

‘Helping Babies Survive: Essential Care for Every Baby’ (ECEB) program: This program uses a low cost, low technology approach to effectively teach caregivers and families the principles of essential newborn care, focusing on hygiene temperature control, breast feeding and signs of infection.