Abstract
OBJECTIVE
Carnitine transfer across the placenta occurs predominantly during the third trimester. Unless L-carnitine is provided, very preterm infants develop carnitine deficiency. Although breast milk and infant formulas contain L-carnitine, parenteral nutrition solutions do not routinely provide L-carnitine. We hypothesized that prolonged L-carnitine supplementation in very preterm infants would improve weight gain and shorten length of stay in the hospital.
STUDY DESIGN
The study was a double-blind parallel placebo-controlled randomized clinical trial. Eligible patients were <29 weeks of gestation, <72 hours of age, and did not have a potentially life-threatening congenital malformation or hereditary metabolic disorder. Patients were stratified by gestational age (23 to 256/7 and 26 to 286/7 weeks), and randomized to receive, either L-carnitine at a dose of 50?μmol/kg/day, or placebo. Carnitine was provided intravenously until the infants tolerated 16?ml/day of feeds. The sample size was calculated to have 80% power to detect a 10% increase in weight gain from birth until 36 weeks of postmenstrual age or discharge from the hospital. Secondary outcome variables included food efficiency (defined as weight gain divided by caloric intake), weight gain at 4 weeks of age, time to regain birth weight and length of stay.
RESULTS
Among the 63 infants enrolled in the trial, 32 were randomized to L-carnitine and 31 to placebo. L-Carnitine supplementation did not significantly affect average daily weight gain from birth until 36 weeks or hospital discharge, or any of the secondary outcome variables.
CONCLUSION
Prolonged supplementation of L-carnitine did not improve long-term weight gain in very preterm infants.
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Acknowledgements
Preliminary results were presented at the New York Perinatal Society, New York, NY, 5/28/02, at the Annual Meeting of the Eastern Society for Pediatric Research, Old Greenwich, CT, 3/23/03, and at the Annual Meeting of the Society for Pediatric Research at Seattle, WA, 5/6/03. We thank all the parents for allowing their babies to participate in this study, the personnel of the pharmacy and the neonatal intensive care unit at Weiler Hospital for their help in conducting the trial. We thank the attendings and fellows, neonatal nurse practitioners, family nurse practitioner and physician assistants who helped recruit patients and conduct the trial. We thank all members of the IRB who participated in the DSMB for this study: Katherine Freeman, MPH, Morri Markowitz, MD, Shlomo Shinnar, MD and Mark Sinnett, PharmD. We also thank Ruth E.K. Stein, MD and Andrew D. Racine, MD for reviewing the first version of the manuscript.
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Pande, S., Brion, L., Campbell, D. et al. Lack of Effect of L-Carnitine Supplementation on Weight Gain in Very Preterm Infants. J Perinatol 25, 470–477 (2005). https://doi.org/10.1038/sj.jp.7211334
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DOI: https://doi.org/10.1038/sj.jp.7211334
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