Hoghton 1996.
| Methods | Single‐blind randomized controlled trial | |
| Participants | Number: 62 enrolled Inclusion criteria: children <3 years of age who had acute gastroenteritis of less than 7 days duration, with liquid stools and increased frequency of defecation but with no other associated illness Exclusion criteria: presence of severe vomiting or in those with >5% dehydration |
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| Interventions | 1. Oral rehydration therapy (ORT) with glucose electrolyte solution alone for 24 to 48 hours without food: 33 participants 2. ORT with a modified diet: 29 participants |
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| Outcomes | Duration of diarrhoea (reported as median, range); percentage weight gain; consistency of stool output; vomiting episodes; incidence of lactose intolerance | |
| Setting | Hospital based trial Location: Casualty department of Bristol Children's Hospital, Bristol, UK |
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| Notes | Who was blinded was unclear. There were 62 infants recruited in the study: Group 1 had 33 participants while Group 2 had 29. One in each group was withdrawn by their parents. For the outcome of vomiting, we considered 32 participants for Group 1 and 28 participants for Group 2. We included a participant supposedly withdrawn from Group 2 for severe vomiting who had to be hospitalized. Duration of diarrhoea and percentage change in weight gain were reported as median and therefore were not included in the meta‐analysis. Length of follow up was 5 days. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given in trial report |
| Allocation concealment (selection bias) | Unclear risk | No details given in trial report |
| Blinding (performance bias and detection bias) All outcomes | Low risk | The study indicated that the patients were randomly allocated into two groups in a single‐blinded fashion, although it was unclear who was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 27 out of 29 and 32 out of 33 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 | Unclear risk | No details given in trial report |