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A Randomized Controlled Trial

Maria Makrides, BSc, BND, PhD; Robert A. Gibson, BSc, PhD; Andrew J. McPhee, MBBS; Carmel T. Collins, RN, BSSc, PhD; Peter G. Davis, MBBS, MD; Lex W. Doyle, MBBS, MSc, MD; Karen Simmer, MBBS, PhD; Paul B. Colditz, MBBS, PhD; Scott Morris, MBBS, PhD; Lisa G. Smithers, BAppSc, PhD; Kristyn Willson, BSc(Hons); Philip Ryan, MBBS, BSc

JAMA. 2009;301(2):175-182.

Context  Uncertainty exists about the benefit of dietary docosahexaenoic acid (DHA) on the neurodevelopment of preterm infants.

Objective  To determine the effect of meeting the estimated DHA requirement of preterm infants on neurodevelopment at 18 months' corrected age.

Design, Setting, and Participants  Randomized, double-blind controlled trial enrolling infants born at less than 33 weeks' gestation from April 2001 to October 2005 at 5 Australian tertiary hospitals, with follow-up to 18 months.

Intervention  High-DHA (approximately 1% total fatty acids) enteral feeds compared with standard DHA (approximately 0.3% total fatty acids) from day 2 to 4 of life until term corrected age.

Main Outcome Measures  Bayley Mental Development Index (MDI) at 18 months' corrected age. A priori subgroup analyses were conducted based on randomization strata (sex and birth weight <1250 g vs 1250 g).

Results  Of the 657 infants enrolled, 93.5% completed the 18-month follow-up. Bayley MDI scores did not differ between the high- and standard-DHA groups (mean difference, 1.9; 95% confidence interval [CI], –1.0 to 4.7). The MDI among girls fed the high-DHA diet was higher than girls fed standard DHA in unadjusted and adjusted analyses (unadjusted mean difference, 4.7; 95% CI, 0.5-8.8; adjusted mean difference, 4.5; 95% CI, 0.5-8.5). The MDI among boys did not differ between groups. For infants born weighing less than 1250 g, the MDI in the high-DHA group was higher than with standard DHA in the unadjusted comparison (mean difference, 4.7; 95% CI, 0.2-9.2) but did not reach statistical significance following adjustment for gestational age, sex, maternal education, and birth order (mean difference, 3.8; 95% CI, –0.5 to 8.0). The MDI among infants born weighing at least 1250 g did not differ between groups.

Conclusion  A DHA dose of approximately 1% total fatty acids in early life did not increase MDI scores of preterm infants overall born earlier than 33 weeks but did improve the MDI scores of girls.

Trial Registration  anzctr.org.au Identifier: ACTRN12606000327583

Author Affiliations: Child Nutrition Research Centre, Women's and Children's Health Research Institute, Women's and Children's Hospital and Flinders Medical Centre (Drs Makrides, Gibson, Collins, and Smithers), Schools of Paediatrics and Reproductive Health (Drs Makrides, Collins, and Smithers), Agriculture, Food and Wine (Dr Gibson), and Population Health and Clinical Practice (Ms Willson and Dr Ryan), University of Adelaide, Department of Neonatal Medicine, Women's and Children's Hospital (Dr McPhee), Centre for Perinatal Medicine, Flinders Medical Centre (Dr Morris), and Department of Paediatrics and Child Health, Flinders University (Drs Makrides and Smithers), Adelaide, Australia; Neonatal Services, Royal Women's Hospital and University of Melbourne, Melbourne, Australia (Drs Davis and Doyle); Neonatal Unit, King Edward Memorial Hospital and University of Western Australia, Perth, Australia (Dr Simmer); and Perinatal Research Centre and Neonatal Unit, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane, Australia (Dr Colditz).

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