Skip to main content
. 2011 Feb 16;2011(2):CD003315. doi: 10.1002/14651858.CD003315.pub3

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.