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. 2017 Mar 10;2017(3):CD000376. doi: 10.1002/14651858.CD000376.pub4

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