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. 2011 Jul 6;2011(7):CD007296. doi: 10.1002/14651858.CD007296.pub2

Gazala 1988.

Methods Randomized controlled trial
Participants Number: 90 enrolled
Inclusion criteria: 1 to 12 months, acute (<4 days duration) watery (at least 4 watery stools per day) diarrhoea, mild dehydration
Interventions 1. Refeeding was started after 6 hours of oral rehydration with ORS
2. Refeeding was started after 24 hours of rehydration.
Outcomes Percentage weight gain, duration of diarrhoea, number of infants admitted to the hospital
Setting Private out‐patient trial
Location: Primary care clinic in Rahat, Israel
Notes Clinical features were assessed at 24 hours and 2 weeks following the initial visit We assumed that the reported number of infants admitted to the hospital are interval numbers between the 2 follow‐up evaluations
Thirty percent of the infants were lost to follow‐up during the 2‐week period
Percentage weight change was reported but not its SD
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The study started on Sunday and infants were randomly assigned, starting on the last day of the week (Friday), to either group by flipping a coin, then alternated everyday. The daily change was to minimize mothers belonging to one group from influencing other mothers in a different group.
Allocation concealment (selection bias) High risk Those assigning will be able to decipher the next treatment allocation for the subsequent days after the initial flipping of the coin
Blinding (performance bias and detection bias) 
 All outcomes High risk Participants and caregivers were not blinded, but it was not mentioned if the outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk 16 out of 53 and 11 out of 37 in the early and late refeeding group, respectively, were not reported in the assessment of outcome 2 weeks following initial visit
Selective reporting (reporting bias) Unclear risk No details given in trial report
Other bias High risk Thirty percent of patients lost to follow up