Neurodevelopmental outcomes at 7 years' corrected age in preterm infants who were fed high-dose docosahexaenoic acid to term equivalent: a follow-up of a randomised controlled trial

carmel collins, Robert Gibson, Peter Anderson, andrew mcphee, Thomas Sullivan, Jacqueline Gould, Philip Ryan, Lex Doyle, Peter Davis, Judy McMichael, French Noel, Paul Colditz, Karen Simmer, Scott Morris, Maria Makrides

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    Abstract

    Objective: To determine if improvements in cognitive outcome detected at 18 months' corrected age (CA) in infants born <33 weeks' gestation receiving a high-docosahexaenoic acid (DHA) compared with standard-DHA diet were sustained in early childhood. Design: Follow-up of a multicentre randomised controlled trial. Randomisation was stratified for sex, birth weight (<1250 vs ≥1250 g) and hospital. Setting: Five Australian tertiary hospitals from 2008 to 2013. Participants: 626 of the 657 participants randomised between 2001 and 2005 were eligible to participate. Interventions: High-DHA (≈1% total fatty acids) enteral feeds compared with standard-DHA (≈0.3% total fatty acids) from age 2-4 days until term CA. Primary outcome: Full Scale IQ of the Wechsler Abbreviated Scale of Intelligence (WASI) at 7 years CA. Prespecified subgroup analyses based on the randomisation strata (sex, birth weight) were conducted. Results: 604 (92% of the 657 originally randomised) consented to participate (291 high-DHA, 313 standard-DHA). To address missing data in the 604 consenting participants (22 for primary outcome), multiple imputation was performed. The Full Scale IQ was not significantly different between groups (high-DHA 98.3, SD 14.0, standard-DHA 98.5, SD 14.9; mean difference adjusted for sex, birthweight strata and hospital -0.3, 95% CI -2.9 to 2.2; p=0.79). There were no significant differences in any secondary outcomes. In prespecified subgroup analyses, there was a significant sex by treatment interaction on measures of parent-reported executive function and behaviour. Scores were within the normal range but girls receiving the high-DHA diet scored significantly higher (poorer outcome) compared with girls receiving the standard-DHA diet. Conclusions: Supplementing the diets of preterm infants with a DHA dose of approximately 1% total fatty acids from days 2-4 until term CA showed no evidence of benefit at 7 years' CA. Trial registration number: Australian New Zealand Clinical Trials Registry: ACTRN12606000327583.

    Original languageEnglish
    Article numbere007314
    Pages (from-to)e007314
    Number of pages11
    JournalBMJ Open
    Volume5
    Issue number3
    DOIs
    Publication statusPublished - 2015

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    collins, C., Gibson, R., Anderson, P., mcphee, A., Sullivan, T., Gould, J., Ryan, P., Doyle, L., Davis, P., McMichael, J., Noel, F., Colditz, P., Simmer, K., Morris, S., & Makrides, M. (2015). Neurodevelopmental outcomes at 7 years' corrected age in preterm infants who were fed high-dose docosahexaenoic acid to term equivalent: a follow-up of a randomised controlled trial. BMJ Open, 5(3), e007314. [e007314]. https://doi.org/10.1136/bmjopen-2014-007314