Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2020

Study Completion Date

December 28, 2021

Conditions
PrematurityNeurodevelopmental DisorderCarnitine Deficiency
Interventions
DRUG

L-carnitine

Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.

DRUG

5% Dextrose

Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients.

Trial Locations (2)

10461

Montefiore Medical Center - Jack D. Weiler Division, The Bronx

10466

Montefiore Medical Center - Wakefield Division, The Bronx

All Listed Sponsors
collaborator

The Gerber Foundation

OTHER

lead

Montefiore Medical Center

OTHER

NCT01783041 - Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants | Biotech Hunter | Biotech Hunter