Methods |
Single‐centre RCT in China |
Participants |
N = 121. Included: infants of gestational age 37 to 40 weeks. Exclusion criteria: infants with congenital anomalies
LCPUFA supplemented formula: N = 69
Control formula: N = 52
Gestational age and birth weight details not available |
Interventions |
LCPUFA group was given milk formula enriched with DHA and AA. LCPUFA content of the formula was not clear. Control group was fed with standard milk formula without DHA and AA added. Infants were randomly assigned to the study formula before 2 weeks of life. Assigned diets were fed from day of enrolment to 6 months of age. Source of LCPUFA was not clear |
Outcomes |
Fatty acid profiles in red cell lipids, physical growth and neurodevelopmental outcomes at 3 and 6 months of age |
Notes |
Study authors published a short version of the article in a Chinese medical journal. The full article with raw data was provided by study authors on request. Study authors also clarified study methods. Breast‐fed reference group = 26 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Method used to generate random sequence was unclear |
Allocation concealment (selection bias) |
Unclear risk |
Method used for allocation concealment was unclear |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of intervention and outcome assessors was performed |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Follow‐up rate was 48% at 3 months and 33% at 6 months |
Selective reporting (reporting bias) |
Unclear risk |
Details not available |
Other bias |
Unclear risk |
Details not available |