Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial

Abstract

SummaryBackgroundThe 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.MethodsWe 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.FindingsBetween 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.InterpretationManagement 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.FundingNational Institute for Health Research, Health Technology Assessment programme.

Oxygen saturation, periodic breathing, and sleep apnea in infants aged 1-4 months old living at 3200 meters above sea level

“…This is a highly relevant issue for acute respiratory tract infection programs where pulse oximetry has become an essential tool for making clinical decisions. 10,11 The median PB was 7.2% and was significantly higher than that published at sea level, which was reported to be 1.1% among young infants, 12 and was also higher than that reported at 2560 MASL, which was 4.9%. 6 The CSAI was higher than that observed at 2560 MASL 6 and much higher than that published at sea level.…”

Predicting Escalated Care in Infants With Bronchiolitis

“…16,28 Our decision to use <90% as a threshold is based on the latest American Academy of Pediatrics recommendation 1 and on recent evidence revealing comparable outcomes in patients discharged with a saturation threshold of 90% vs 94%. 58 Interestingly, duration of symptoms was not associated with escalated care in this study. Although previous evidence for this association has yielded disparate results, 16,19,20,23 a large multisite study revealed that symptom duration <1 day predicts the need for ICU care in bronchiolitis.…”

Duration of intravenous antibiotic therapy for children with acute osteomyelitis or septic arthritis: a feasibility study

“…94 Other information that will be important to include in the pre-trial information includes data to support the switch point in both standard care and the experimental intervention, details of how a child would be monitored to ensure infection was being dealt with, trajectory of care in case of failure to recover in the shorter treatment arm, and data to demonstrate safety of the shorter arm and regarding the equivalence/equipoise about treatment in both arms.…”