Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates
Levit OL, Calkins KL, Gibson LC, Kelley-Quon L, Robinson DT, Elashoff DA, Grogan TR, Li N, Bizzarro MJ, Ehrenkranz RA
JPEN. Journal of parenteral and enteral nutrition · 35 citas
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Alimentación controladaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
- Consumo medido con
- Comida provista por los investigadores
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Indiana Clinical and Translational Sciences Institute
- Gobierno
- National Institutes of Health
- Universidad u hospital
- University of California, Los Angeles
- Gobierno
- U.S. Public Health Service
- Gobierno
- National Institute of General Medical Sciences
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Gobierno
- NCATS NIH HHS
- Gobierno
- NICHD NIH HHS
- Gobierno
- PHS HHS
- Gobierno
- NIGMS NIH HHS
- Subvenciones
- National Center for Advancing Translational Sciences (UL-1TR000124); Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12 HD-034610); National Institutes of Health (T32G075776‐6); Eunice Kennedy Shriver National Institute of Child Health and Human Development (T32 HD-007094); Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD00140); Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12 HD001400); Indiana Clinical and Translational Sciences Institute (UL1TR000124); National Institute of General Medical Sciences (T32 GM075776); U.S. Public Health Service (T32G075776-6); University of California, Los Angeles (UL1 TR000124); National Institutes of Health (K12HD00140); National Institutes of Health (T32 HD007094)
Según 11 financiadores declarados.
Publicación
- Publicado
- 2014-06-24 · JPEN J Parenter Enteral Nutr · vol. 40 · número 3 · págs. 374–382
- Editorial
- Wiley
- Citado
- 53 citas · más que el 95% de estudios similares · 4.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 23 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Clinical Nutrition and Gastroenterology · Infant Nutrition and Health · Neonatal Respiratory Health Research
- Palabras clave
- Medicine, Calorie, Parenteral nutrition, Cholestasis, Gestational age, Enteral administration, Randomized controlled trial, Confidence interval, Gastroenterology, Internal medicine, Pediatrics, Pregnancy
- MeSH
- humans, cholestasis, bilirubin, soybean oil, fat emulsions, intravenous, treatment outcome, length of stay, gestational age, dose-response relationship, drug, infant, newborn, infant, premature, administration, intravenous
10 autores
- Orly L. Levit🇺🇸 · autor de correspondenciaYale University
- Kara L. Calkins🇺🇸University of California, Los Angeles
- Leena Caroline Gibson🇺🇸University of California, Los Angeles
- Lorraine I. Kelley‐Quon🇺🇸University of California, Los Angeles
- Daniel T. Robinson🇺🇸Northwestern University
- David A. Elashoff🇺🇸University of California, Los Angeles
- Tristan Grogan🇺🇸University of California, Los Angeles
- Ning Li🇺🇸University of California, Los Angeles
- Matthew J. Bizzarro🇺🇸Yale University
- Richard A. Ehrenkranz🇺🇸Yale University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Premature infants depend on intravenous fat emulsions to supply essential fatty acids and calories. The dose of soybean-based intravenous fat emulsions (S-IFE) has been associated with parenteral nutrition (PN)-associated liver disease. This study's purpose was to determine if low-dose S-IFE is a safe and effective preventive strategy for cholestasis in preterm neonates.
Materials and methods
This is a multicenter randomized controlled trial in infants with a gestational age (GA) ≤29 weeks. Patients <48 hours of life were randomized to receive a low (1 g/kg/d) or control dose (approximately 3 g/kg/d) of S-IFE. The primary outcome was cholestasis, defined as a direct bilirubin ≥15% of the total bilirubin at 28 days of life (DOL) or full enteral feeds, whichever was later, after 14 days of PN. Secondary outcomes included growth, length of hospital stay, death, and major neonatal morbidities.
Results
In total, 136 neonates (67 and 69 in the low and control groups, respectively) were enrolled. Baseline characteristics were similar for the 2 groups. When the low group was compared with the control group, there was no difference in the primary outcome (69% vs 63%; 95% confidence interval, -0.1 to 0.22; P = .45). While the low group received less S-IFE and total calories over time compared with the control group (P .2 for all).
Conclusion
Compared with the control dose, low-dose S-IFE was not associated with a reduction in cholestasis or growth.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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