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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborator: The Gerber Foundation

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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