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 |
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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 |
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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 |
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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 |