Kashyap 1986.
| Methods | Randomised controlled trial | |
| Participants | Preterm infants of birth weight 900 to 1750 g (excluding infants with gastrointestinal tract, renal, or respiratory problems) | |
| Interventions |
Sole diet: Nutrient‐enriched formula (N = 11)
Standard formula (N = 12)
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| Outcomes | Time to regain birth weight Rate of weight, length, and head circumference gain Rate of skinfold thickness gain ‐ triceps and subscapular |
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| Identification |
Sponsorship source: US National Institute of Health Research grants (HD13020, AM27358, RR00645); Bristol‐Myers Grant Setting: Department of Pediatrics, Columbia University College of Physicians & Surgeons, USA (early 1980s) |
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| Notes | Infants were randomised into 3 groups. Only data from group 1 ("standard formula") and group 3 ("nutrient‐enriched formula") were included in this review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "...assigned randomly shortly after birth to receive one of three formulas" ‐ sequence generation not described. |
| Allocation concealment (selection bias) | Low risk | Allocated colour‐coded formula ‐ investigators and nurses did not know how the codes applied to the formulas |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Formula containers were colour coded, with code known to neither the investigator nor nurses caring for the infants |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome assessments likely to include complete cohort |
| Selective reporting (reporting bias) | Low risk | A trial protocol could not be found, but data for all outcomes described in the methods section of the paper were reported in the results |
| Other bias | Unclear risk | The study was funded by a pharmaceutical company. It is unclear if this company was also the manufacturer of the formulas used in the study Infants in the standard formula group had slightly higher mean birth weight |