Methods |
Single‐centre RCT conducted in Dallas, Texas, USA |
Participants |
N = 79. Inclusion criteria: infants of gestational age 37 to 40 weeks, singleton births and appropriate for gestational age. Exclusion criteria: family history of milk protein allergy or genetic or familial eye disease, maternal vegetarian or vegan dietary pattern, maternal metabolic disease, anaemia or infection, congenital malformation or infection, jaundice, perinatal asphyxia, meconium aspiration syndrome, admission to NICU
LCPUFA (DHA and AA) supplemented formula: N = 27
LCPUFA (DHA alone) supplemented formula: N = 26
Control formula: N = 26
Mean gestational age and birth weight: not given |
Interventions |
One group was fed with formula milk enriched with DHA (0.36%) and AA (0.72%). Another group was fed formula milk enriched with DHA alone (0.36%). Control group was fed standard milk formula without DHA and AA added. Infants were randomly assigned to the study formula between 1 and 5 days of life. Assigned diets were fed from within 5 days of birth until 17 weeks of age. Source of LCPUFA was single‐cell oil |
Outcomes |
Blood lipids were measured at 17 and 52 weeks. Growth, sweep VEP and forced preferential looking were measured at 6, 17, 26 and 52 weeks. Bayley Scales of Infant Development were measured at 18 months |
Notes |
Breast‐fed reference: n = 29 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Use of block randomisation schedule |
Allocation concealment (selection bias) |
Low risk |
Use of sealed envelopes |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Investigators conducting blood lipid analysis and visual function testing were masked to type of formula provided to infants |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
70% to 86% follow up for different outcomes |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
Other bias |
Low risk |
Appears to be free of other biases |