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Ensayo controlado aleatorizado2019

Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial

Bernabe-García M, Villegas-Silva R, Villavicencio-Torres A, Calder PC, Rodríguez-Cruz M, Maldonado-Hernández J, Macías-Loaiza D, López-Alarcón M, Inda-Icaza P, Cruz-Reynoso L

JPEN. Journal of parenteral and enteral nutrition · 46 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
Consejo Nacional de Ciencia y Tecnología
Gobierno
Instituto Mexicano del Seguro Social
Gobierno
Consejo Nacional de Ciencia y Tecnología, Guatemala
Subvenciones
Instituto Mexicano del Seguro Social (FIS/IMSS/PROT/G15/1462 from IMSS); Consejo Nacional de Ciencia y Tecnología, Guatemala (Salud‐2015‐2‐261765); Consejo Nacional de Ciencia y Tecnología (Salud‐2015‐2‐261765)

Según 3 financiadores declarados.

Publicación

Publicado
2019-01-06 · JPEN J Parenter Enteral Nutr · vol. 43 · número 7 · págs. 874–882
Editorial
Wiley
Citado
55 citas · más que el 94% de estudios similares · 3.9× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
54 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Retinopathy of Prematurity Studies · Neonatal Respiratory Health Research · Fatty Acid Research and Health
Palabras clave
Retinopathy of prematurity, Medicine, Odds ratio, Enteral administration, Randomized controlled trial, Docosahexaenoic acid, Relative risk, Gestational age, Confidence interval, Confounding, Internal medicine, Parenteral nutrition, Incidence (geometry), Birth weight, Neonatal intensive care unit, Pediatrics, Gastroenterology, Pregnancy, Polyunsaturated fatty acid, Fatty acid, Biology
MeSH
humans, retinopathy of prematurity, infant, premature, diseases, docosahexaenoic acids, enteral nutrition, parenteral nutrition, logistic models, double-blind method, infant, newborn, infant, low birth weight, infant, premature, female, male

10 autores

  • Mariela Bernabé-García🇲🇽 · autor de correspondenciaMexican Social Security Institute; Centro Medico Nacional Siglo XXI
  • Raúl Villegas‐Silva🇲🇽Hospital Infantil de México Federico Gómez
  • Astrid Villavicencio‐Torres🇲🇽Mexican Social Security Institute; Centro Médico Nacional La Raza
  • Philip C. Calder🇬🇧National Health Service; Southampton General Hospital; University Hospital Southampton NHS Foundation Trust; National Institute for Health and Care Research; University of Southampton
  • Maricela Rodríguez‐Cruz🇲🇽Mexican Social Security Institute; Centro Medico Nacional Siglo XXI
  • Jorge Maldonado‐Hernández🇲🇽Mexican Social Security Institute; Centro Medico Nacional Siglo XXI
  • Denisse Macías‐Loaiza🇲🇽Mexican Social Security Institute; Centro Medico Nacional Siglo XXI
  • Mardia López‐Alarcón🇲🇽Mexican Social Security Institute; Centro Medico Nacional Siglo XXI
  • Patricia Inda Icaza🇲🇽Universidad Anáhuac
  • Leonardo Cruz‐Reynoso🇲🇽Mexican Social Security Institute; Centro Médico Nacional La Raza

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Retinopathy of prematurity (ROP) is a disorder of the retina of low-birth-weight preterm infants that potentially leads to blindness. Docosahexaenoic acid (DHA), is protective in experimental models, but its administration as part of parenteral nutrition has shown inconsistent results. We test the effect of enteral DHA to prevent ROP and/or severity and to reduce hospital stay.

Methods

This was a double-blind parallel clinical trial. Preterm infants (n = 110; 55 per group) with birth weight <1500 g but ≥1000 g were recruited in a neonatal intensive care unit. Infants were randomized to receive 75 mg of DHA/kg/d (DHA group) or high oleic sunflower oil (control group) for 14 days by enteral feeding. The effect of DHA was evaluated on any stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay. Groups were compared with relative risk (RR) and 95% confidence interval (CI), Fisher's exact test, Student's t-test, or Mann-Whitney U-test, as appropriate. Logistic regression was applied to adjust for confounders.

Results

There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33). However, patients who received DHA showed lower risk for stage 3 ROP (RR for DHA = 0.66; 95% CI, 0.44-0.99; P = 0.03). After adjusting for confounders, this decreased risk remained significant (adjusted odds ratio = 0.10; 95% CI, 0.011-0.886; P = 0.04). Hospital stay was similar between groups.

Conclusion

Enteral DHA may reduce the incidence of stage 3 ROP.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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