| Methods |
Single‐centre RCT conducted in Adelaide |
| Participants |
N = 83. Inclusion criteria: healthy term infants. Exclusion criteria: small for gestational age, congenital disease, infants of insulin‐dependent diabetic mothers, history of drug or alcohol abuse in the mother
LCPUFA (DHA and AA) supplemented formula: N = 28 (GA 39.8 ± 1.3 weeks; BW 3549 ± 521 grams)
LCPUFA (DHA alone) supplemented formula: N = 27 (GA 39.6 ± 1.1 weeks, BW 3378 ± 431 grams)
Control formula: N = 28 (GA 39.6 ± 1.5 weeks, BW 3549 ± 497 grams) |
| Interventions |
'LCPUFA' group was given milk formula enriched with DHA (0.34%) and AA (0.34%). Another LCPUFA group received milk formula enriched with DHA alone (0.34%). Control group was fed standard milk formula without DHA and AA added. Infants were randomly assigned to study formula within 7 days of life. Assigned milk formula was sole source of nutrition for 4 months. Subsequently, study formula was the only source of milk until 1 year of age. Source of LCPUFA was egg yolk phospholipids (DHA + AA group) and tuna oil (DHA group) |
| Outcomes |
Plasma and RBC fatty acid levels at 6, 16 and 34 weeks and 1 year of age. Physical growth at 6, 16 and 34 weeks and at 1 and 2 years of age. VEP at 16 and 34 weeks. Bayley Scales of Infant Development at 1 and 2 years |
| Notes |
Breast‐fed reference group, n = 63 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random numbers |
| Allocation concealment (selection bias) |
Low risk |
Adequate; use of sealed opaque envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Investigators and families were blinded to randomisation |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
60% to 85% for various outcomes |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
| Other bias |
Low risk |
Appears to be free of other biases |
