Darzi 1996.
Methods | Single‐centre RCT. 6 week intervention, 7 to 13 month follow‐up. Conducted in India. | |
Participants | 40 babies with cleft lip alone. Those with associated clefts of the palate and those greater than 6 months of age excluded. Age: Gp1 = 4.35 months, Gp2 = 4.5 months. Gender (m/f): not stated. Complete cleft lip: Gp1 = 13, Gp2 = 12. Incomplete cleft lip: Gp1 = 7, Gp2 = 8. | |
Interventions | Gp1. Breastfeeding (postsurgical) (n = 20). Gp2. Spoon‐feeding (postsurgical) (n = 20). All CL were repaired when child was 3 to 6 months old. | |
Outcomes | Weight (kg) recorded at 3 and 6 weeks post‐surgery. Adverse events and cost data also reported. | |
Notes | Funding not stated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Infants were allocated by asking mothers to pick a numbered slip of paper from a well shuffled box containing 40 numbered slips of paper, 20 for breast feeding and 20 for spoon feeding. |
Allocation concealment? | Unclear risk | Not reported. |
Blinding? All outcomes | Unclear risk | Not reported. |
Incomplete outcome data addressed? All outcomes | Low risk | No drop outs in study. |
Free of selective reporting? | High risk | No length measurement provided. No head circumference measurement provided. |
Free of other bias? | Low risk | Suitable follow‐up at 6‐weeks post‐surgery. Comparable baseline data. |