Dataset Information

Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis: an internal 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 standard care in a control group. 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 in the full RCT 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.

SUBMITTER: Andersson-Marforio S

PROVIDER: S-EPMC8966163 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis: an internal feasibility study of a randomised control trial.

Andersson-Marforio Sonja S Lundkvist Josenby Annika A Hansen Christine C Ekvall Hansson Eva E

Pilot and feasibility studies 20220330 1

<h4>Background</h4>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 standard care in a control group. The objective of this internal pilot study was to addres ...[more]

PMID: 35351205

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Project description:BackgroundNo definite consensus has been reached yet on the best treatment strategy for the large group of infants hospitalised with bronchiolitis or pneumonia. Minimal handling is often recommended, although not evaluated scientifically. There is a need to evaluate the management, as the infants often are critically affected, and the costs for society are high. The aim of this RCT was to evaluate the most common physiotherapy intervention in Sweden for this patient group, including frequent changes in body position and stimulation of physical activity, compared to standard care.MethodsInfants 0-24 months old, without previous cardiac or respiratory diagnoses and born in gestational week 35+, were recruited in two Swedish hospitals. The participants (n=109) were randomised to either interventions in addition to standard care (intervention group) or to standard care alone (control group). The primary outcome measure was time to improvement. The secondary outcomes were immediate changes in oxygen saturation, heart rate and respiratory rate, time to improved general condition (parents' assessment), and lung complications.ResultsThe median time to improvement was 6 hours in both groups (p=0.54). The result was similar when we adjusted for age in months, sex, tobacco smoke exposure, heredity for asthma/atopic disease, and early stage of the infection (for those with RSV), p=0.69. Analyses of the immediate changes showed no significant differences either (p=0.49-0.89). Time to improved general condition was median 3 hours in the intervention group and 6 hours in the control group, p=0.76. No lung complications occurred.ConclusionsNo statistically significant differences in outcomes were detected between the intervention group and the control group. Both strategies were found to be equally effective and safe, indicating that the current recommendation of minimal handling for these infants should be reconsidered. Furthermore, the findings suggest that this treatment can be safely continued.

Project description:Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis.We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246) or nasal suction (NS, control group, n=250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73) for the control group and 2.02 days (95% CI 1.96-2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33). No treatment by age interaction was found (p=0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively). No difference between groups in bradycardia with or without desaturation (RR=1.0, 95% CI 0.2-5.0, p=1.00 and RR=3.6, 95% CI 0.7-16.9, p=0.10, respectively) was found during the procedure. Parents reported that the procedure was more arduous in the group treated with IET (mean difference=0.88, 95% CI 0.33-1.44, p=0.002), whereas there was no difference regarding the assessment of the child's comfort between both groups (mean difference=-0.07, 95% CI -0.53 to 0.38, p=0.40). No evidence of differences between groups in intensive care admission (RR=0.7, 95% CI 0.3-1.8, p=0.62), ventilatory support (RR=2.5, 95% CI 0.5-13.0, p=0.29), and antibiotic treatment (RR=1.0, 95% CI 0.7-1.3, p=1.00) was observed.IET + AC had no significant effect on time to recovery in this group of hospitalized infants with bronchiolitis. Additional studies are required to explore the effect of chest physiotherapy on ambulatory populations and for infants without a history of atopy.ClinicalTrials.gov NCT00125450.

Project description:ImportanceIn developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care.ObjectiveTo determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis.Design, setting, and participantsThis international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020.InterventionsInterventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback.Main outcomes and measuresThe primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions.ResultsA total of 26 hospitals were randomized without dropouts. Analysis was by intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001).Conclusions and relevanceTargeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12616001567415.

Project description:IntroductionBronchiolitis is the most common reason for hospitalisation in infants in developed countries. The main focus of hospital care is on supportive care, such as monitoring for hypoxia and supplemental oxygen administration, as active therapies lack effectiveness. Pulse oximetry is used to monitor hypoxia in hospitalised infants and is used either intermittently or continuously. Observational studies have suggested that continuous pulse oximetry use leads to a longer length of hospital stay in stable infants. The use of continuous pulse oximetry may lead to unnecessary clinical intervention due to readings that are of little clinical significance, false-positive readings and less reliance on the clinical status. There is a lack of high-quality evidence to guide which pulse oximetry monitoring strategy, intermittent or continuous, is superior in infants hospitalised with bronchiolitis with respect to patient and policy-relevant outcomes.Methods and analysisThis is a multicentre, pragmatic randomised controlled trial comparing two strategies for pulse oximetry monitoring in infants hospitalised for bronchiolitis. Infants aged 1 month to 2 years presenting to Canadian tertiary and community hospitals will be randomised after stabilisation to receive either intermittent or continuous oxygen saturation monitoring on the inpatient unit until discharge. The primary outcome is length of hospital stay. Secondary outcomes include additional measures of effectiveness, acceptability, safety and cost. We will need to enrol 210 infants in order to detect a 12-hour difference in length of stay with a type 1 error rate of 5% and a power of 90%.Ethics and disseminationResearch ethics approval has been obtained for this trial. This trial will provide data to guide hospitals and clinicians on the optimal pulse oximetry monitoring strategy in infants hospitalised with bronchiolitis. We will disseminate the findings of this study through peer-reviewed publication, professional societies and meetings.Trial registration numberNCT02947204.

Dataset Information

Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis: an internal feasibility study of a randomised control trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis: an internal feasibility study of a randomised control trial.

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