Zomer 2012 NED.
| Methods | Cluster‐RCT Allocation sequence: unclear Allocation concealment: not described Blinding: open Inclusion of participants in the analysis: adequate Length of follow‐up: November 2011 to March 2012 Cluster‐adjustment method: adjusted |
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| Participants | Number: 71 day‐care centres (DCC) (intervention 36; control 35) with 545 children (278 from 34 intervention DCC and 267 from 35 control DCC) Inclusion criteria: children attended the DCC at least two days a week, aged between 6 months and 3 to 5 years, intended to attend the DCC throughout the trial period, if their parents consented, were Dutch speaking and had access to e‐mail or regular post. Exclusion criteria: if the child had chronic illness, if the child was on medication that predisposed him/her to infection and if was sibling is taking part in the trial (one per child per family participant) Age: children between 6 months to 60 months |
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| Interventions | Intervention (see Table 5 for detailed description):
Control:
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| Outcomes |
Not used in this review:
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| Notes | Location: Rotterdam‐Rijnmond, Gouda and Leiden regions of Netherlands Duration: September 2011 to April 2012 (7 months) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified randomized allocation. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 553 children included in the trial; 545 included in the analysis. |
| Selective reporting (reporting bias) | Unclear risk | Not observed. |
| Other bias | High risk | There were some differences in baseline characteristics between intervention and control group. "...the crude incidence of diarrhoeal episodes differed between intervention and control DCCs at baseline..." |