Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

October 27, 2019

Study Completion Date

August 28, 2021

Conditions
Intraventricular HemorrhagePeriventricular LeukomalaciaBrain InjuryRenal Injury
Interventions
DRUG

Indomethacin

indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants

PROCEDURE

delay in umbilical cord clamp at birth

provision of a \~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)

DRUG

placebo infusion

saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)

PROCEDURE

immediate cord clamp at birth

no delay in umbilical cord clamp; \<10sec (recorded in delivery note)

Trial Locations (1)

40506

Kentucky Childrens Hospital Neonatal Intensive Care Unit, Lexington

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Hong Huang

OTHER

NCT02221219 - Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury | Biotech Hunter | Biotech Hunter