Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial
Keim SA, Boone KM, Klebanoff MA, Turner AN, Rausch J, Nelin MA, Rogers LK, Yeates KO, Nelin L, Sheppard KW
JAMA pediatrics · 33 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- March of Dimes Foundation
- Universidad u hospital
- Nationwide Children's Hospital
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NCATS NIH HHS
- Subvenciones
- National Center for Advancing Translational Sciences (UL1TR001070)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2018-10-25 · JAMA Pediatr · vol. 172 · número 12 · pág. 1126
- Editorial
- American Medical Association
- Citado
- 47 citas · más que el 95% de estudios similares · 4.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 48 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Fatty Acid Research and Health · Infant Development and Preterm Care · Infant Nutrition and Health
- Palabras clave
- Medicine, Toddler, Pediatrics, Bayley Scales of Infant Development, Randomized controlled trial, Placebo, Docosahexaenoic acid, Gestational age, Gestation, Psychological intervention, Internal medicine, Polyunsaturated fatty acid, Cognition, Psychomotor learning, Pregnancy, Fatty acid, Psychiatry, Developmental psychology
- MeSH
- erythrocytes, humans, docosahexaenoic acids, fatty acids, capsules, treatment outcome, drug administration schedule, child development, cognition, dietary supplements, infant, infant, newborn, infant, premature, female, male, medication adherence, biomarkers
10 autores
- Sarah A. Keim🇺🇸 · autor de correspondenciaNationwide Children's Hospital; The Ohio State University
- Kelly M. Boone🇺🇸Nationwide Children's Hospital; The Ohio State University
- Mark A. Klebanoff🇺🇸Nationwide Children's Hospital; The Ohio State University
- Abigail Norris Turner🇺🇸The Ohio State University
- Joseph R. Rausch🇺🇸Nationwide Children's Hospital; The Ohio State University
- Mary Ann Nelin🇺🇸Nationwide Children's Hospital
- Lynette Kay Rogers🇺🇸Nationwide Children's Hospital; The Ohio State University
- Keith Owen Yeates🇨🇦University of Calgary; Alberta Children's Hospital; Hotchkiss Brain Institute
- Leif Daniel Nelin🇺🇸Nationwide Children's Hospital; The Ohio State University
- Kelly W. Sheppard🇺🇸Nationwide Children's Hospital; The Ohio State University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Intake of dietary docosahexaenoic acid (DHA) among toddlers is low. Supplementation may benefit developmental outcomes of toddlers who were born preterm.
Objective
To determine whether 6 months of daily DHA supplementation improves developmental outcomes of toddlers who were born preterm.
Design, setting, and participants
A randomized, fully masked, placebo-controlled trial was conducted from April 26, 2012, to March 24, 2017, at a large US pediatric academic center with 9 neonatal intensive care units. Children born at less than 35 weeks' gestation who were 10 to 16 months corrected age underwent 6 months of intervention. Of 2363 children assessed, 982 were eligible, 605 declined, and 377 enrolled and were randomized. Analyses were according to intent to treat.
Interventions
One-to-one allocation to receive daily microencapsulated DHA, 200 mg, and arachidonic acid (AA), 200 mg (DHA+AA), or microencapsulated corn oil (placebo).
Main outcomes and measures
The primary outcome specified a priori was Bayley Scales of Infant and Toddler Development, third edition (Bayley-III), cognitive composite score at 16 to 22 months corrected age. Secondary outcomes were Bayley-III language and motor composite scores and Infant Behavior Questionnaire-Revised and Early Childhood Behavior Questionnaire effortful control and activity level scores. Subgroup analyses defined a priori were by income, sex, and birth weight.
Results
Among 377 children randomized and included in the analysis (182 girls and 195 boys; median corrected age, 15.7 months), 338 children (89.7%) had complete data on the primary outcome. Bayley-III cognitive scores did not differ between the DHA+AA and placebo groups (difference in change, 0.5 [95% CI, -1.8 to 2.8]; effect size, 0.05; P = .66). Assignment to the DHA+AA group had a small to medium negative effect on Bayley-III language scores among children with lower birth weights (eg, a child with a birth weight of 1000 g assigned to receive DHA+AA experienced a 4.1-point relative decrease, while a child assigned to placebo did not; P = .03 for interaction). Supplementation had a similar negative effect on effortful control scores among children with annual household incomes greater than $35 000 (difference in change, -0.3 [95% CI, -0.4 to -0.1]; effect size, -0.37; P = .01). Bayley-III motor scores and activity level scores were unaffected.
Conclusions and relevance
Daily supplementation with 200 mg of DHA and 200 mg of AA for 6 months resulted in no improvement in cognitive development and early measures of executive function vs placebo, and may have resulted in negative effects on language development and effortful control in certain subgroups of children. These findings do not support DHA supplementation in the second year of life for children who are born preterm.
Trial registration
ClinicalTrials.gov Identifier: NCT01576783.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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