Agbayani 1981.
Methods | Single centre cluster‐allocation trial. Blinding of randomisation: No. Allocation occurred using a pre‐established list of 6 alternate 2 month blocks of gowning and modified gowning over a 12‐month period. Blinding of intervention: No. Blinding of outcome assessment: Unknown. Completeness of follow‐up: Complete for primary outcomes. Incomplete for subgroup of 273 infants. |
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Participants | A total of 724 outborn (123) and inborn (601) term and preterm infants. A subgroup of 273 newborns who met the following inclusion criteria were swabbed for the presence of colonising bacteria. Inclusion criteria: admitted to the NICU between Monday and Thursday who were less than 12 hours old and who had negative blood cultures on admission. Infants who were enrolled in the last 10 days of each two month interval were excluded. | |
Interventions | No gown: Hands and forearms were washed with povidone‐iodine for two minutes. Jewelry was removed from wrists and fingers. Nurses wore scrub gowns. Street clothes were worn by physicians, other staff and visitors. Gown: As for no gown periods but gowns were donned before entering the nursery. In both gown and no gown groups, gowns were worn by anyone holding an infant. Anterior nares, umbilicus and groin were swabbed on admission to the nursery and on days 2,4,7,10,14,21 and 28 only among the subgroup of infants. | |
Outcomes | 1) Death before discharge 2) Systemic nosocomial infection, defined by documented sepsis, meningitis and necrotising enterocolitis. 3) Localised nosocomial infection, defined as conjunctivitis, pustules and abscesses. 4) Colonisation (prevalence of bacteria from the nares, umbilicus and groin) amongst the subgroup at 7 different time points from day 1 to day 28. | |
Notes | This trail was analysed as if allocation was by individual. It was unclear how all infections were diagnosed. Pathology results were available for systemic infections but not for localised infections. Death, systemic and localised infection was reported for the whole sample. Colonisation data was available for a subgroup of 273 infants. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | High risk | Single centre cluster‐allocation trial Allocation occurred using a pre‐established list of 6 alternate 2 month blocks of gowning and modified gowning over a 12‐month period |
Allocation concealment? | High risk | Blinding of randomisation: No |
Blinding? All outcomes | Unclear risk | Blinding of intervention: No Blinding of outcome assessment: Unknown |
Incomplete outcome data addressed? All outcomes | Unclear risk | Complete for primary outcomes. Incomplete for subgroup of 273 infants. |