Phase 3
N=144
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Prematurity · Neurodevelopmental Disorder · Carnitine Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01783041 ↗Enrolled (actual)
144
Serious AEs
29.2%
Results posted
Mar 2022
Primary outcome: Primary: Time to Regain Birthweight in Infants Who Receive L-carnitine Supplementation Compared to Controls — 8.12; 8.4 days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- L-carnitine (Drug); 5% Dextrose (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Regain Birthweight in Infants Who Receive L-carnitine Supplementation Compared to Controls |
8.12; 8.4 | <0.05 sig |
| PRIMARY Neurodevelopment Indices in Infants Who Receive L-carnitine Supplementation Compared to Controls (NNNS) |
4.66; 4.29; 0.073; 0.079; 4.6; 4.6 | <0.05 sig |
| SECONDARY Brain Volumes in Infants Who Received L-carnitine Supplementation Compared to Controls |
19372; 18189; 6050; 5832; 8611; 8217 | <0.05 sig |
| SECONDARY Rate of Head Growth in Infants Who Receive L-carnitine Supplementation Compared to Controls |
30.6; 30.4 | <0.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01783041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.