Rush 1990.
Methods | Single centre randomised controlled trial: Blinding of randomisation: Yes, by sealed envelope. Blinding of Intervention: No Blinding of outcome: yes Complete follow‐ up: No, due to culture reports missing or research staff unavailable to abstract data |
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Participants | 473 infants. Sample drawn from 1130 infants consecutively admitted to a newborn nursery. Inclusions: >2500 grams, at least 37 weeks gestation and Apgar at 5 minutes > 7 at 5 minutes. Exclusions: infants initially admitted to the NICU. | |
Interventions | No gown: No cover gowns were worn by staff or visitors during any infant contact. Gown: Staff and visitors wore cover gowns for all infant contact. In both groups, staff members, parents and visitors continued to be advised to wash their hands carefully before providing patient care. Nasal & umbilical swabs were taken by nursing staff on the 3rd postnatal day or before discharge, whichever was the sooner. | |
Outcomes | 1) Nasal colonisation 2) Umbilical colonisation 3) Colonisation of nose and umbilicus Clarification was requested and received for whether (i) all staff followed the protocol (ii) how infections were diagnosed and when, (iv) clarification of Table 2 and (v) how cost of gowns was estimated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Single centre randomised controlled trial |
Allocation concealment? | Low risk | Blinding of randomisation: Yes, by sealed envelope |
Blinding? All outcomes | High risk | Blinding of Intervention: No Blinding of outcome: Yes |
Incomplete outcome data addressed? All outcomes | High risk | Complete follow‐up: No, due to culture reports missing or research staff unavailable to abstract data |