Docosahexaenoic Acid and Bronchopulmonary Dysplasia in Preterm Infants
Collins CT, Makrides M, McPhee AJ, Sullivan TR, Davis PG, Thio M, Simmer K, Rajadurai VS, Travadi J, Berry MJ, Liley HG, Opie GF, Tan K, Lui K, Morris SA, Stack J, Stark MJ, Chua MC, Jayagobi PA, Holberton J, Bolisetty S, Callander IR, Harris DL, Gibson RA
The New England journal of medicine · 140 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Medical Research Council
Según 1 financiador declarado.
Publicación
- Publicado
- 2017-03-29 · N Engl J Med · vol. 376 · número 13 · págs. 1245–1255
- Editorial
- Massachusetts Medical Society
- Citado
- 176 citas · más que el 99% de estudios similares · 10.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 32 trabajos
- Acceso
- De pago
- Áreas de investigación
- Neonatal Respiratory Health Research · Infant Nutrition and Health · Fatty Acid Research and Health
- Palabras clave
- Bronchopulmonary dysplasia, Medicine, Enteral administration, Gestational age, Retinopathy of prematurity, Necrotizing enterocolitis, Pediatrics, Randomized controlled trial, Confidence interval, Relative risk, Docosahexaenoic acid, Birth weight, Gestation, Respiratory distress, Parenteral nutrition, Internal medicine, Polyunsaturated fatty acid, Surgery, Pregnancy, Fatty acid
- MeSH
- humans, bronchopulmonary dysplasia, docosahexaenoic acids, emulsions, regression analysis, double-blind method, gestational age, infant, newborn, infant, premature, female, male
24 autores
- Carmel T Collins🇦🇺South Australian Health and Medical Research Institute
- Maria Makrides🇦🇺South Australian Health and Medical Research Institute
- Andrew J McPhee🇦🇺South Australian Health and Medical Research Institute; The University of Adelaide
- Thomas Sullivan🇬🇧Faculty of Public Health
- Peter Graham Davis🇦🇺Royal Women's Hospital; The University of Melbourne; Flinders University
- Marta Thió🇦🇺Royal Women's Hospital; The University of Melbourne; Flinders University; Murdoch Children's Research Institute
- Karen Norrie Simmer🇦🇺The University of Sydney; The University of Western Australia
- Victor Samuel Rajadurai🇸🇬National University of Singapore; KK Women's and Children's Hospital
- Javeed Travadi🇦🇺John Hunter Children's Hospital
- Mary Judith Berry🇳🇿University of Otago
- Helen G. Liley🇦🇺The University of Queensland; Mater Misericordiae Hospital; Mater Research
- Gillian F. Opie🇦🇺Mercy Hospital for Women
- Kenneth Tan🇦🇺Monash Children’s Hospital; Monash University
- Kei Lui🇦🇺UNSW Sydney
- Scott Adam MorrisIndiana University School of Medicine
- JACQUELINE A. STACK🇦🇺Liverpool Hospital; UNSW Sydney
- Michael John Stark🇺🇸🇦🇺Robinson Memorial Hospital; The University of Adelaide
- M. C. Chua🇸🇬National University of Singapore; KK Women's and Children's Hospital
- Pooja Agarwal Jayagobi🇸🇬KK Women's and Children's Hospital
- James Holberton🇦🇺Mercy Hospital for Women
- Srinivas Bolisetty🇦🇺Royal Hospital for Women
- Ian Callander🇦🇺Liverpool Hospital
- Deborah L. Harris🇳🇿University of Auckland; Waikato Hospital
- Robert Alan Gibson🇦🇺Wine Australia; South Australian Health and Medical Research Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Studies in animals and in humans have suggested that docosahexaenoic acid (DHA), an n-3 long-chain polyunsaturated fatty acid, might reduce the risk of bronchopulmonary dysplasia, but appropriately designed trials are lacking.
Methods
We randomly assigned 1273 infants born before 29 weeks of gestation (stratified according to sex, gestational age [<27 weeks or 27 to <29 weeks], and center) within 3 days after their first enteral feeding to receive either an enteral emulsion providing DHA at a dose of 60 mg per kilogram of body weight per day or a control (soy) emulsion without DHA until 36 weeks of postmenstrual age. The primary outcome was bronchopulmonary dysplasia, defined on a physiological basis (with the use of oxygen-saturation monitoring in selected infants), at 36 weeks of postmenstrual age or discharge home, whichever occurred first.
Results
A total of 1205 infants survived to the primary outcome assessment. Of the 592 infants assigned to the DHA group, 291 (49.1% by multiple imputation) were classified as having physiological bronchopulmonary dysplasia, as compared with 269 (43.9%) of the 613 infants assigned to the control group (relative risk adjusted for randomization strata, 1.13; 95% confidence interval [CI], 1.02 to 1.25; P=0.02). The composite outcome of physiological bronchopulmonary dysplasia or death before 36 weeks of postmenstrual age occurred in 52.3% of the infants in the DHA group and in 46.4% of the infants in the control group (adjusted relative risk, 1.11; 95% CI, 1.00 to 1.23; P=0.045). There were no significant differences between the two groups in the rates of death or any other neonatal illnesses. Bronchopulmonary dysplasia based on a clinical definition occurred in 53.2% of the infants in the DHA group and in 49.7% of the infants in the control group (P=0.06).
Conclusions
Enteral DHA supplementation at a dose of 60 mg per kilogram per day did not result in a lower risk of physiological bronchopulmonary dysplasia than a control emulsion among preterm infants born before 29 weeks of gestation and may have resulted in a greater risk. (Funded by the Australian National Health and Medical Research Council and others; Australian New Zealand Clinical Trials Registry number, ACTRN12612000503820 .).
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