The Division of Neonatal–Perinatal Medicine is committed to improving neonatal care by engaging in clinical research. Our faculty have diverse research interests and are involved in national and global research. We work collaboratively with Duke Neonatal Perinatal Research Unit as a NICHD Neonatal Research Network (NRN) site and the Pediatric Trials Network (PTN) www.pediatrictrials.org . Some of the many studies that we are currently involved in are listed below.
For further information on these studies, please contact:
Janice Bernhardt, MS, RN
Director, Neonatal Clinical Research
Generic Database (GDB) - The Generic Data Base Study (GDB): Survey of Morbidity and Mortality in High Risk Preterm Infants
This study includes data from 18 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
Infants born at less than 27 weeks gestational age are assessed at 22-26 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.
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
Outcomes at 18-22 months Adjusted Age This study will assess, whether the initial surgical treatment of ELBW infants who have NEC or IP should be a laparotomy or percutaneous drain.
Hydrocortisone BPD (A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22-26 Months of Age in Intubated Infants Less than 30 Weeks Gestational Age)
A randomized, placebo controlled, trial to study the efficacy and safety of a 10‐day tapering course of hydrocortisone treatment for infants less than 30 weeks estimated gestational age at birth who remain intubated at 14 ‐ 28 days postnatal age.
Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care
This is a Pediatric Trials Network multi-center trial will enroll babies and children to age 20. Pharmacokinetics, pharmacodynamics, influence of genetic factors, metabolic and protein profiles on therapeutics of specific understudied drugs will be studied.
Molecular Mechanisms Associated with Immune Maturation in Infants
This is a collaborative project with Dr. Kristina Abel (UNC-CH Microbiology and Immunology Department) to define molecular mechanisms associated with immune development in preterm and full term infants through analyses of blood and saliva samples during the first year of life.
MILK Study (Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in ELBW Infants)
This study compares neurodevelopmental outcomes in infants fed donor human milk or preterm formula.
Transfusion of Prematures Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?
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.
Pharmocokinetics of Sildenafil in Premature Infants is an open-label, PK and safety profile study of sildenafil in premature infants.
Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections (SCAMP) is a study designed to evaluate the safety of 3 therapeutic regimens in premature infants (<34 weeks GA) with complicated intra-abdominal infections. This study will also evaluate the CSF PK of metronidazole, clindamycin, and piperacillin-tazabactam in infants with suspected or confirmed infections.
Preemie Cooling (A randomized trial of targeted temperature management with whole body hypothermia for moderate and severe neonatal encephalopathy in premature infants 33-35 weeks gestational age--a Bayesian study). Infants between 33 and 356/7 weeks gestational age and > 1500 grams birth weight who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE) will be randomized to whole body hypothermia (33.5oC esophageal temperature) for 72 hours or normothermia to determine if cooling is safe and will reduce death or moderate/severe disability at 18-22 months corrected age.
Ongoing Research Projects
The Neonatal Neurobehavior and Outcomes in Very Preterm Infants (NOVI) Study is funded by NICHD grant 1R01HD072267-01A1. In order to improve NICU care and better meet infant and family needs, the goal of the NOVI Study is to identify as early as possible newborn and family characteristics that are associated with later neurodevelopment. NOVI plans to enroll over 800 infants born prior to 30 wks gestational age (PMA) during their NICU stay. Our study sites include 9 NICUs affiliated with 6 universities participating in the Vermont-Oxford Network (VON). NICU data collection includes medical complications and treatments, reliable centralized readings of brain images at day of life 7-14 and at 36-40 weeks PMA. Assessments during the week of NICU discharge include the NICU Network Neurobehavioral Scale (NNNS), infant vocalization acoustics, cheek swabs to analyze epigenetic features (DNA methylation), and maternal interviews about socioenvironmental characteristics and well-being. Follow-up at 24 +/-2 months AGA includes maternal interviews, swab and analysis of DNA methylation, the Bayley-III or Vineland Adaptive Behavior Scale-II, Child Behavior Checklist (CBCL), Modified Checklist for Autism in Toddlers (MCHAT-R; an autism risk screening measure), and the Gross Motor Function Classification System (GMFCS) to classify cerebral palsy severity. We support our study families with referrals and assistance to meet their own needs, and our findings will potentially provide a high impact breakthrough to identify the most vulnerable infants early enough to initiate targeted preventive interventions during NICU care.
Accelerating Adoption of Comparative Effectiveness Research in Premature Infants
This NIH-sponsored partnership between UNC and Duke University seeks to improve short and long-term outcomes in very low birth weight infants by modifying practices based on results of comparative effectiveness research.
Assessing Cognitive and Practical Changes Following the Introduction of a Neonatal Training and Newborn Program in Ghana
Cognitive changes after completion of specific neonatal resuscitation and newborn training modules for skilled birth attendants (nurses, midwives, physicians and nurse anesthetists) in Ghana, West Africa are assessed.
Simplified Regimens for Management of Possible Serious Bacterial Infections in Neonates and Young Infants for Use in Outpatient and Community Setting: A Multi-Centre Randomized Controlled Trial in Africa
This is a multi-centre randomized control trial in Africa to establish whether a simplified antibiotic regiment is effective in the treatment of sepsis in neonates and young infants.
A Full Service Diagnostic Laboratory for a Rural Health Center, Equateur Province, Democratic Republic of Congo
This pilot project involves equipping a health center in the Equateur Province with full diagnostic capabilities utilizing hand operated or solar energy powered equipment. Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo The overall goal of the Caterpillar Cereal Study is to prevent malnutrition among young children in the Democratic Republic of the Congo by incorporating a caterpillar-based cereal into complementary feeding.