Willats 1998.
| Methods | Single‐centre RCT in Scotland | |
| Participants | N = 72. Included: term infants (37 to 42 weeks) with birth weight between 2.5 and 4 kg. Exclusion criteria: not mentioned LCPUFA supplemented formula: N = 34 Control formula: N = 38 Mean birth weight and gestational age data of study infants not given | |
| Interventions | LCPUFA formula was enriched with DHA (0.15% to 0.25%) and AA (0.3% to 0.4%). Control formula did not contain DHA or AA. Study milk formula was given from birth until 4 months of age. Source of LCPUFA was egg lipids, milk fat and vegetable oils | |
| Outcomes | Infant cognition measured by a means‐end problem‐solving test at 10 months. Assessments of intelligence quotient (IQ), attention control (Day‐Night Test) and speed of processing on Matching Familiar Figures Test (MFFT) was done at 6 years for enrolled infants | |
| Notes | Results are given as medians and quartiles and therefore are provided in text, not in tables. No breast‐fed control group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Use of computer‐generated randomisation table. Randomisation was stratified to ensure sex matching |
| Allocation concealment (selection bias) | Low risk | Pharmacy coded formulae administered to babies |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Mothers and investigators were unaware of group assignments |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Completeness of follow‐up: 44 of 72 (61%) infants completed study outcome assessment |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported |
| Other bias | Low risk | Appears to be free of other biases |
AA: arachidonic acid AGA: appropriate for gestational age BSID: Bayley Scales of Infant Development BW: body weight DHA: docosahexaenoic acid EPA: eicosapentaenoic acid GA: gestational age GLA: gamma‐linolenic acid HIV: human immunodeficiency virus IUGR: intrauterine growth rate LCPUFA: long chain polyunsaturated fatty acids MDI: Mental Developmental Index NICU: neonatal intensive care unit PDI: Psychomotor Developmental Index PMA: postmenstrual age RBC: red blood cells RCT: randomised controlled trial VEP: visual evoke potentials