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. 2003 Apr 22;2003(2):CD003670. doi: 10.1002/14651858.CD003670

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
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