Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Neurology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/13/2018 |
| Start Date: | January 2013 |
| End Date: | August 2020 |
| Contact: | Mamta Fuloria, MD |
| Email: | mfuloria@montefiore.org |
| Phone: | 718-904-4105 |
A Double-Blind, Controlled, Randomized Clinical Trial of the Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
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.
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.
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
We found this trial at
2
sites
Bronx, New York 10466
Principal Investigator: Mamta Fuloria, MD
Phone: 718-904-4105
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