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

Santosham 1990.

Methods Randomly assigned
Participants Number: 200 enrolled
Inclusion criteria: children 3 to 18 months with acute watery diarrhoea (<7 days duration, at least 5 watery stools per day)
Exclusion criteria: exclusively breastfed, with illness requiring intravenous fluids or antibiotic therapy, <5% dehydration, clinical signs of kwashiorkor
Interventions 1. Glucose oral rehydration solution (G‐ORS) for 4 hours followed by soy‐based formula (SF): 50 participants
2. G‐ORS for 4 hours followed by rice‐based formula: 50 participants
3. Rice‐based ORS for 24 hours followed by SF: 50 participants
4. G‐ORS for 4 hours followed by pre‐cooked rice: 50 participants
Outcomes Stool output during the first 24 hours and during illness (ml/kg); percentage weight gain during illness; duration of diarrhoea (hrs); serum sodium and potassium on admission, during and at resolution of illness
Setting Hospital based trial
Location: Abu El‐Reeche Hospital, Cairo, Egypt
Notes The third group (R‐ORS § SF), which continued to receive R‐ORS for the first 24 hours of the maintenance period followed by a soy‐based lactose‐free formula, was considered late refeeding or the control group in this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Enrolled infants were randomly assigned in blocks of eight to one of four groups.
Allocation concealment (selection bias) Unclear risk No details given in trial report
Blinding (performance bias and detection bias) 
 All outcomes High risk Participants were not blinded, but it was unclear if the caregivers or the outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 148 out of 150 and 49 out of 50 patients in the early and late refeeding group, respectively, were included in the final analysis
Selective reporting (reporting bias) Unclear risk No details given in trial report
Other bias High risk Eleven percent were lost to follow‐up