Physiotherapy Interventions Including Frequent Changes of the Body Position and Stimulation to Physical Activity for Infants Hospitalised with Bronchiolitis: A Feasibility Study of a Randomised Control Trial

Abstract

Background: The effect of a treatment that includes frequent changes of the body position for infants with bronchiolitis has not been evaluated, although it is often used in Swedish hospitals. Because of this, a randomised control trial (RCT) has begun with the aim to evaluate this treatment, comparing the effect of an individualised physiotherapy intervention, a non-individualised intervention, and a control group receiving standard care. The objective of this internal pilot study was to address uncertainties concerning the ongoing RCT and to determine whether the trial is feasible or not, possibly with adjustments to the protocol.Methods: Descriptive analyses of the recruitment, retention, data supply for the primary end point and the usability of the primary outcome measure were performed. A safety analysis was conducted by an independent analysis group. Results: Ninety-one infants were included, 33 (36.3%), 28 (30.8%), and 30 (33.0%) in the respective allocation groups. Fifty-nine (64.8%) were boys. The median age was 2.5 (min-max: 0.2-23.7) months. They remained in the study for a median of 46 hours (min-max: 2-159). The recruitment rate was 19%. The data supply for the primary end point and for the primary outcome measure was lower than anticipated in the original sample size calculation. Difficulties concerning utilising the primary outcome measure were identified. The safety analysis detected no risks of harm related to participation in the study.Conclusions: It is feasible to continue the RCT with modifications of the analysis plan. Participation in the study was not associated with any safety risks.Trial registration: ClinicalTrials.gov NCT03575091. Registered 2 July 2018. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03575091?term=NCT03575091&rank=1