Shaikh 1991.
| Methods | Randomized controlled trial | |
| Participants | Number: 69 enrolled Inclusion criteria: children 9 to 48 months, acute watery diarrhoea <72 hours, moderate to severe dehydration, no previous antibiotic treatment, no complications other those related to dehydration, weaned from mother's milk |
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| Interventions | 1. 'Khitchri' and half‐strength cow's milk formula in addition to WHO ORS after 4 to 6 hours rehydration: 36 participants 2. WHO ORS with no food in the first 24 hours, then traditional legume‐based weaning diet 'khitchri' and half‐strength cow's milk formula freely: 33 participants |
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| Outcomes | Stool output (g/kg/day), percentage weight gain after start of rehydration and at 24 hours and 72 hours post‐rehydration | |
| Setting | Hospital based trial Location: Civil Hospital, Karachi, Pakistan. |
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| Notes | 6 children were withdrawn and did not complete the study due to intercurrent infections and for non‐medical reasons (2 from Group A, 4 from Group B) Treatment failures were defined as a need to restart administeringintravenous fluids Data were separated from those who were treatment successes and failures; we were not able to extract the data for appropriate meta analysis Vomiting was monitored only until day 3 11 children in Group A and 15 in Group B had high stool rates on day 3 but it was unclear if this persisted for more than 7 days. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were randomly assigned to one of the two treatment groups using a random number table |
| 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 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 32 out of 36 and 31 out of 33 in the early and late refeeding group, respectively, were reported in the final analysis |
| Selective reporting (reporting bias) | Unclear risk | No details given in trial report |
| Other bias | Unclear risk | No details given in trial report |