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- Title
High-Dose Docosahexaenoic Acid in Newborns Born at Less Than 29 Weeks' Gestation and Behavior at Age 5 Years: Follow-Up of a Randomized Clinical Trial.
- Authors
Gould, Jacqueline F.; Roberts, Rachel M.; Anderson, Peter J.; Makrides, Maria; Sullivan, Thomas R.; Gibson, Robert A.; McPhee, Andrew J.; Doyle, Lex W.; Bednarz, Jana M.; Best, Karen P.; Opie, Gillian; Travadi, Javeed; Cheong, Jeanie L. Y.; Davis, Peter G.; Sharp, Mary; Simmer, Karen; Tan, Kenneth; Morris, Scott; Lui, Kei; Bolisetty, Srinivas
- Abstract
Key Points: Question: Does supplementation of docosahexaenoic acid (DHA) to newborns less than 29 weeks' gestation after birth improve their behavioral functioning in childhood? Findings: In this follow-up of a randomized clinical trial of an enteral DHA emulsion in 958 infants born at less than 29 weeks' gestation, there was no evidence for differences in parent-rated behavioral functioning at 5 years' corrected age. Meaning: Increasing neonatal DHA supplementation in infants born at less than 29 weeks' gestation did not influence behavior in early childhood in this study. This randomized clinical trial evaluates behavior at age 5 years among children who received high-dose docosahexaenoic acid as preterm infants. Importance: Children born at less than 29 weeks' gestation are at risk of behavioral difficulties. This may be due in part to the lack of transplacental supply of docosahexaenoic acid (DHA), a key fatty acid with structural and functional roles in the brain. Objective: To determine whether meeting the neonatal DHA requirement through supplementation is associated with improved behavioral functioning of children born at less than 29 weeks' gestation. Design, Setting and Participants: This was a follow-up of children from 10 Australian participating centers in a multi-center, blinded, parallel group randomized clinical trial of infants born at less than 29 weeks' gestation conducted from June 2012 and September 2015, excluding those with additional fatty acid supplementation or major congenital or chromosomal abnormalities. Follow-up took place from August 2018 to May 2021. Parents of surviving children who had not withdrawn from the original trial were invited to complete questionnaires when the child turned 5 years' corrected age. Interventions: Infants were randomized to receive daily enteral emulsions providing 60 mg/kg/d of DHA or a soy-oil emulsion (with no DHA) from within the first 3 days of enteral feeding until 36 weeks' postmenstrual age or discharge home, whichever occurred first. Main Outcomes and Measures: The primary outcome of this follow-up was parent-rated behavior and emotional functioning as indicated by the Total Difficulties score of the Strengths and Difficulties Questionnaire. Parents also completed questionnaires about their child's behavioral manifestations of executive functioning, as well as a range of health outcomes to assess potential longer-term side effects of DHA intervention. Results: Primary outcome data were available for 731 children (76% of 958 surviving eligible children; 361 in the intervention group and 370 in the control group). Of these 731, 452 (47%) were female, and the mean (SD) corrected age at follow-up was 5.4 (0.5) years. Following imputation for missing data, the mean Total Difficulties score was the same in both groups (intervention group, n = 465; mean [SD], 11.8 [6.3]; control group, n = 493; mean [SD], 11.8 [6.0]; mean difference adjusted for sex, gestational age stratum, and hospital, 0.01; 95% CI, −0.87 to 0.89; P =.98). There was no evidence for differences between the groups in any secondary outcomes of behavior, executive functioning, or health. Conclusions and Relevance: In this follow-up of a randomized clinical trial, enteral DHA supplementation at the equivalent of the estimated in utero dose for infants born at less than 29 weeks' gestation did not improve behavioral functioning at age 5 years. There were no indications of adverse effects with DHA supplementation. Trial Registration: Australian New Zealand Clinical Trial Registry: ACTRN12612000503820
- Subjects
DOCOSAHEXAENOIC acid; PARENT attitudes; EXECUTIVE function; CONFIDENCE intervals; FUNCTIONAL status; GESTATIONAL age; NUTRITIONAL requirements; CHILD behavior; EMULSIONS; DIETARY supplements; FUNCTIONAL assessment; RANDOMIZED controlled trials; BEHAVIOR disorders; BEHAVIOR disorders in children; QUESTIONNAIRES; SOY oil; DESCRIPTIVE statistics; CHILDREN'S health; STATISTICAL sampling; ENTERAL feeding; EMOTIONS; LONGITUDINAL method; CHILDREN
- Publication
JAMA Pediatrics, 2024, Vol 178, Issue 1, p45
- ISSN
2168-6203
- Publication type
Article
- DOI
10.1001/jamapediatrics.2023.4924