| Methods |
Two‐centre RCTs conducted in Nottingham and Leicester, England |
| Participants |
N = 309. Inclusion criteria: term infants ≥ 37 weeks' gestation and appropriate for gestational age singletons. Exclusion criteria: presence of congenital anomalies
LCPUFA: 154 (GA 40.0 ± 1.29 weeks and BW 3542 ± 409 grams)
Control formula: 155 (GA 40.1 ± 1.30 weeks and BW 3648 ± 459 grams) |
| Interventions |
'LCPUFA' group was given milk formula enriched with DHA (0.32%) and AA (0.30%). Control group was fed standard milk formula without DHA and AA added. Infants were assigned to study formula within first week of life. Study formula was continued for 6 months. Source of LCPUFA was egg yolk phospholipids |
| Outcomes |
Primary endpoint was development at 18 months assessed by Bayley Scales of Infant Development (MDI and PDI). Secondary endpoint was development at 9 months assessed by Knobloch, Passamanick and Sherrards tests. Growth and gastrointestinal tolerance were also assessed at 6, 9 and 18 months. Incidences of atopy, eczema, wheeze and infection were documented |
| Notes |
Infants who were breast‐fed for at least 6 weeks were a reference group (n = 138). Study authors published a correction to outcomes reported in 2002, stating that they inadvertently reversed the 2 diet codes. Hence the outcomes of standard formula were those of infants fed LCPUFA formula, and vice versa. We have entered the correct data into this review |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A random permuted block design stratified by centre and by sex was used to generate the allocation schedule |
| Allocation concealment (selection bias) |
Low risk |
Use of sealed opaque envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Mothers and study personnel were unaware of the dietary allocation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Follow‐up rates of 81% |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
| Other bias |
Low risk |
Appears to be free of other biases |
