This list features selected current clinical studies by investigators in the Division of Neonatology.

Effect of hydrocortisone on survival and neurodevelopment

  • Overview: 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 infants intubated less than 30 weeks gestational age
  • Objective: 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.

Laparotomy vs. drainage for ELBW infants with NEC or IP

  • Overview: A multicenter 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.
  • Objective: To assess, whether the initial surgical treatment of extremely low birth weight infants who have necrotizing enterocolitis or intestinal perforation and require surgical treatment should be laparotomy or percutaneous drain.
  • Study details and criteria available online.

Cooling strategies for neonatal HIE

  • Overview: Optimizing cooling strategies at less than 6 hours of age for neonatal hypoxic-ischemic encephalopathy (HIE)
  • Objective: Evaluate whether whole body cooling initiated at less than 6 hours of age and continues for a duration of 120 hours or a depth at 32.1 degrees C in infants less than or equal to 36 weeks gestation with hypoxic ischemic encephalopathy will reduce death and disability at 18 months of age.
  • Study details and criteria available online.

Secondary studies:

  • Prediction of outcome in hypoxic-ischemic encephalopathy using amplitude integrated encephalopathy
  • SMaRT pilot feasibility study: a systematic monitoring of aEEG during rewarming optimizing trial 

Donor milk vs. formula for ELBW infants

  • Overview: Neurodevelopmental effects of donor human milk vs. preterm formula in extremely low birth weight (ELBW) infants
  • Objective: To determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount.
  • Study details and criteria available online.

Biomarkers, NEC and sepsis

  • Overview: A biologic sample study for the validation of biomarkers of progressive necrotizing enterocolitis (NEC) and sepsis
  • Objective: To verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on biosensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples
  • Study details and criteria available online.

PCR, CSF and bacterial meningitis 

  • Overview: The impact of bacterial polymerase chain reaction (PCR) and cerebrospinal fluid (CSF) cytokine levels on the diagnosis of bacterial meningitis in infants
  • Objective: To compare the results of conventional culture methods with a broad range 16S rRNA PCR assay followed by DNA sequencing to detect bacteria in the CSF. Investigators hypothesize that meningitis is under-diagnosed in infants. They expect that the PCR test will identify the causative organism more often than conventional cultures, particularly in the face of prior antibiotic administration.

Hypothermia and HIE

  • Overview: Evaluation of hypothermia initiated after 6 hours of age for infants less than or equal to 36 weeks gestational age with hypoxic-ischemic encephalopathy: a Bayesian evaluation


  • Overview: Transfusion of prematures

VIP in preterm infants

  • Overview: Vocal cord injury in preterm infants (VIP): a pilot cohort study

Neonatal sepsis

  • Overview: Patterns of immune marker elevations in neonatal sepsis phenotypes
Last Updated: May 14, 2014