| Methods |
Three‐centre RCT in Kansas, Portland and Seattle |
| Participants |
N = 134. Inclusion criteria: term infants ≥ 37 weeks' gestation, AGA. Exclusion criteria: Apgar score < 7 at 5 minutes, physical or metabolic defects, received IV lipid infusion or blood transfusion, mothers with diabetes, hyperlipidaemia or perinatal infection
LCPUFA (DHA and AA) group: N = 46 (GA 39.3 ± 1.3 weeks, BW 3.50 ± 0.46 kg)
LCPUFA (DHA alone) group: N = 43 (GA 39.7 ± 1.2 weeks, BW 3.54 ± 0.46 kg)
Control group: N = 45 (GA 39.8 ± 1.1 weeks, BW 3.600 ± 0.47 kg) |
| Interventions |
DHA plus AA formula was enriched with DHA (0.13%) and AA (0.45%). DHA alone formula was enriched with DHA (0.2%). Control formula was standard milk without addition of DHA and AA. Infants were randomised within 9 days after birth. Study formulae were fed ad libitum as the sole source of nutrition for first 4 months and as exclusive milk beverage up to 12 months of age. Source of LCPUFA was egg yolk phospholipids |
| Outcomes |
RBC fatty acid levels at 2, 4, 6 and 12 months. Growth measured at 1, 2, 4, 6, 9 and 12 months. Visual acuity at 2, 4, 6, 9, 12 and 39 months. Visual acuity measured by the Teller acuity card procedure or sweep spatial frequency VEP. Global development assessed at 1 year (BSID) and at 3 years (Stanford Binet IQ). Language development assessed at 14 months (McArthur Communicative Development Inventory) and at 3 years (Peabody Picture Vocabulary Test) |
| Notes |
Breast‐fed reference group: n = 63. Study authors had provided additional information for the previous version of this review. We contacted them to request more information for this update. Study authors acknowledged receipt of our letter but did not provide requested information |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Centralised randomisation |
| Allocation concealment (selection bias) |
Low risk |
Centralised randomisation |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Assessors of developmental outcomes were unaware of infants' group assignment and medical history |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Outcomes of only infants who completed the study were reported. Less than 80% follow‐up for visual acuity outcomes at different ages |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
| Other bias |
Low risk |
Appears to be free of other biases |
