72469
document
Oxygen saturation targets in infants with bronchiolitis ( BIDS ) : a double-blind , randomised , equivalence trial . BACKGROUND The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90 % for children with bronchiolitis , which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections . No evidence exists to support this threshold . We aimed to assess whether the 90 % or higher target for management of oxygen supplementation was equivalent to a normoxic 94 % or higher target for infants admitted to hospital with viral bronchiolitis . METHODS We did a parallel-group , randomised , controlled , equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK ( the Bronchiolitis of Infancy Discharge Study [ BIDS ] ) . A central computer randomly allocated ( 1:1 ) infants , in varying length blocks of four and six and without stratification , to be clipped to standard oximeters ( patients treated with oxygen if pulse oxygen saturation [ SpO2 ] < 94 % ) or modified oximeters ( displayed a measured value of 90 % as 94 % , therefore oxygen not given until SpO2 < 90 % ) . All parents , clinical staff , and outcome assessors were masked to allocation . The primary outcome was time to resolution of cough ( prespecified equivalence limits of plus or minus 2 days ) in the intention-to-treat population . This trial is registered with ISRCTN , number ISRCTN28405428 . FINDINGS Between Oct 3 , and March 30 , 2012 , and Oct 1 , and March 29 , 2013 , we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters . Cough resolved by 15·0 days ( median ) in both groups ( 95 % CI for difference -1 to 2 ) and so oxygen thresholds were equivalent . We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group . In the standard care group , eight infants transferred to a high-dependency unit , 23 were readmitted , and one had a prolonged hospital stay . In the modified care group , 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital . Recorded adverse events did not differ significantly . INTERPRETATION Management of infants with bronchiolitis to an oxygen saturation target of 90 % or higher is as safe and clinically effective as one of 94 % or higher . Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children , particularly in developing nations where resources are scarce . FUNDING National Institute for Health Research , Health Technology Assessment programme .
72470
Intervention_Pharmacological
oxygen supplementation
72471
Intervention_Physical
standard oximeters
72472
Intervention_Physical
modified oximeters
72473
Outcome_Physical
oxygen saturation
72474
Outcome_Physical
time to resolution of cough
72475
Outcome_Physical
Cough
72476
Outcome_Adverse-effects
35 serious adverse events
72477
Outcome_Adverse-effects
25 serious adverse events
72478
Outcome_Mental
infants transferred to a high-dependency unit
72479
Outcome_Mortality
were readmitted
72480
Outcome_Physical
a high-dependency unit
72481
Outcome_Mental
were readmitted to hospital
72482
Participant_Age
infants
72483
Participant_Condition
bronchiolitis ( BIDS )
72484
Participant_Age
children
72485
Participant_Condition
lower respiratory tract infections
72486
Participant_Age
infants aged 6 weeks to 12 months of age
72487
Participant_Condition
bronchiolitis
72488
Participant_Sample-size
308 infants
72489
Participant_Age
infants
72490
Participant_Condition
bronchiolitis