Expired Study
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Bronx, New York 10461


Purpose:

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.


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


NCT ID:

NCT01783041


Primary Contact:

Principal Investigator
Mamta Fuloria, MD
Montefiore Medical Center


Backup Contact:

N/A


Location Contact:

Bronx, New York 10461
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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