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 |
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Interventions | 1. Refeeding was started after 6 hours of oral rehydration with ORS 2. Refeeding was started after 24 hours of rehydration. |
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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 |
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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 |
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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 |