| Methods |
Single‐centre RCT conducted in France |
| Participants |
N = 24. Inclusion criteria: healthy term appropriate for gestational age infants. Exclusion criteria: infants of mothers who had history of cocaine or alcohol abuse, hyperlipidaemia, diabetes, strict vegetarian or vegan diets
LCPUFA supplemented formula: N = 12 (GA 39.3 ± 1.1 weeks, BW 3.378 ± 0.426 kg)
Control formula: N = 12 (GA 40.1 ± 1.2 weeks, BW 3.311 ± 0.0448 kg) |
| Interventions |
'LCPUFA' group was given milk formula enriched with DHA (0.31%). Control group was fed standard milk formula without DHA added. Assigned diets were fed from day 3 of life until 4 months of age. Source of LCPUFA was fish oil |
| Outcomes |
Fatty acid levels in RBCs at 4 months; weight, length and head circumference at 2 and 4 months of age |
| Notes |
Study authors responded by providing additional information regarding study methods |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Use of computer‐generated random allocation list |
| Allocation concealment (selection bias) |
Low risk |
Use of sealed opaque envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Caregivers, parents and outcome assessors were blinded to the intervention group |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Follow‐up > 80% |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
| Other bias |
Low risk |
Appears to be free of other biases |
