Makrides 1995.
Methods | Single‐centre RCT conducted in Adelaide Sample size calculation: yes Concealment of allocation: yes Blinding to intervention: yes Blinding to outcome assessment: yes Completeness of follow‐up: no (60% to 81% for various primary outcomes) |
|
Participants | N = 32. Inclusion criteria: healthy term appropriate for gestational age infants born at 37 to 42 weeks. Exclusion criteria: infants of mothers who had history of lipid metabolism disorders, diabetes, drug or alcohol abuse LCPUFA supplemented formula: N = 13 (GA 39.1 ± 1.7 weeks, BW 3.288 ± 0.525 kg) Control formula: N = 19 (GA 39.6 ± 1.2 weeks, BW 3.650 ± 0.0416 kg) | |
Interventions | 'LCPUFA' group was given milk formula enriched with DHA (0.35%). In addition, formula was enriched with EPA and GLA. Control group was fed standard milk formula without DHA and AA added. Assigned diets were fed from birth to 30 weeks of life. Source of LCPUFA was fish oil and evening primrose oil | |
Outcomes | Plasma and red blood cell fatty acid levels at 6, 16 and 30 weeks; visual evoked potential acuity at 16 and 30 weeks; Bayley Scales of Infant Development at 1 year | |
Notes | Breast‐fed reference group, n = 28 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of central computerised randomisation |
Allocation concealment (selection bias) | Low risk | Adequate; use of sealed opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Mothers were unaware of formula type |
Incomplete outcome data (attrition bias) All outcomes | High risk | 60% to 81% follow‐up for various primary outcomes |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported |
Other bias | Low risk | Appears to be free of other biases |