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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency

In brief

Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.

Key facts

Study ID

NCT01783041

Run by

Montefiore Medical Center

People needed

144

Starts

2013-01-01

Expected to finish

2021-12-28

Last updated by the study team

2023-03-08

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born at equal to or less than 30 weeks gestation and with birth weight < 1250 grams
• Less than 72 hours of age
• Signed parental consent

You may not qualify if…

• Critically ill infants with life expectancy less than 72 hours
• Inability to obtain consent within 72 hours of birth
• Potentially life-threatening congenital anomalies
• Known hereditary metabolic disorders
• Known chromosomal abnormalities
• Terratogen exposure with symptomatic substance withdrawal
• Congenital viral infections
• Microcephaly
• Grade IV intraventricular hemorrhage or seizures documented within the first 72 hours of life

Where it is running

• Montefiore Medical Center - Jack D. Weiler Division — The Bronx, New York, United States
• Montefiore Medical Center - Wakefield Division — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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