Conway 1989.
| Methods | Randomized controlled trial | |
| Participants | Number: 200 enrolled Inclusion criteria: 6 weeks to 12 months, fed on formula feeds, with acute onset of watery or extremely loose stools for less than 14 days, no systemic illness Exclusion criteria: None |
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| Interventions | 1. Oral rehydration solution (Dextrolyte, Cow and Gate) for 24 hours, followed by 24 hours of half strength and 24 hours of three‐quarter strength SMA Gold Cap (Wyeth) before continued feeding with the full strength formula milk: 50 participants 2. HN25 formula (Milupa) for two days after the stools returned to normal followed, on successive days, by replacement of one, three, and then all HN25 feeds by full strength SMA Gold Cap: 50 participants 3. Continued feeding with full strength SMA Gold Cap from the time of admission: 50 participants 4. Continued feeding with Formula S (Cow and Gate) from the time of admission. 50 participants |
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| Outcomes | Duration of diarrhoea after admission, percentage weight change noted on days 2 and 5 and on discharge | |
| Setting | Hospital based trial Location: Seacroft Hospital admissions, Leeds, UK |
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| Notes | Data from Group 2, 3 and 4 were combined in the early refeeding group Data on weight change was only presented in a graph format Only one patient in Group 2 had persistent diarrhoea but recorded only until day 10 One patient in group 1 had continuous vomiting but it was not clear how long it lasted Location: Seacroft Hospital admissions in Leeds |
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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 | 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 | All patients who were randomized 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 |