Clinical Investigations

Clinical Investigations

The Division of Neonatology has played an important role in performing clinical trials in neonates by participating as one of the 16 sites for the NICHD Neonatal Research Network, which has been internationally recognized for findings that have led to significant advances in the clinical care of newborn infants. The goal of participation in the network is to improve the care and outcome of neonates, especially very-low-birth-weight infants less than 1500 grams. The division participates in the follow-up studies for extremely-low-birth-weight infants and the database registry for infants less than 29 weeks. Ongoing clinical trials include participation in the SUPPORT trial comparing early CPAP to early surfactant with mechanical ventilation and the Late Hypothermia trial evaluating systemic hypothermia initiated after 6 hours of age for term infants with hypoxic-ischemic encephalopathy. Upcoming network protocols will investigate the administration of inositol to prevent retinopathy of prematurity, hydrocortisone treatment for hypotension in neonates, optimization of hypothermia for hypoxic-ischemic encephalopathy, and genetic contributions to diseases of prematurity.

Under the leadership of Dr. Kurt Schibler, additional areas of clinical investigation in the division focus on the development of necrotizing enterocolitis in premature infants, the development of the oral flora in preterm infants, renal insufficiency in newborns, and optimal treatment of neonatal seizures. Current efforts are underway to identify biomarkers associated with necrotizing enterocolitis, sepsis,  bronchopulmonary dysplasia, and renal insufficiency.

For further information, please visit the faculty sites listed below:

Suhas Kallapur, MD Pharmacokinetics of Montelukast in preterm infants
Kurt Schibler, MD Biomarkers of necrotizing enterocolitis


Necrotizing entercolitis.
Necrotizing enterocolitis (NEC) is the most common and serious GI disorder affecting neonates, occurring in 5-8% of very-low-birth-weight premature infants. Babies with NEC present with abdominal distension, feeding intolerance, and an abnormal x-ray. The exact cause of NEC remains unknown. Researchers in the division are working to identify biomarkers for NEC, helping to identify those at risk early to provide timely intervention.