Physiotherapy for Infants With Bronchiolities
Physiotherapy Including Frequent Changes of Body Position and Stimulation to Physical Activity for Infants With Bronchiolitis and Other Acute Respiratory Infections - a Randomized Controlled Trial
1 other identifier
interventional
120
1 country
2
Brief Summary
Children who are in a hospital with respiratory distress often have difficulty breathing, have thick mucus, and may find it hard to eat normally. Sometimes physical therapy is used to treat these children, but it is not entirely known which methods help the children's condition. The aim of this study is to evaluate the most common physiotherapy treatment method that is currently in use in Sweden for infants who are hospitalized with a lower respiratory infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedStudy Start
First participant enrolled
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 30, 2021
September 1, 2021
4.4 years
October 13, 2017
September 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to improvement
First improvement regarding any of the following: Wang respiratory score, use of supplemented oxygen, use of supplemented high air flow, use of tube feeding, hospital stay
Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
Secondary Outcomes (5)
oxygen saturation
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
respiratory rate
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Heart rate
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
General condition, parents' assessment
Baseline and every third hour up to discharge from hospital, no more than two weeks
Lung complications
At discharge from the ward, no more than two weeks
Study Arms (3)
control group
NO INTERVENTIONThe infants will receive the standard care at the ward.
Non-individualized
EXPERIMENTALThe parents will be guided manually by the nursing staff and receive written information about how to change body positions of their child regularly throughout the hospital stay.
Individualized
EXPERIMENTALThe infant will receive frequent changes of body positions, stimulation to physical activity, and stimulation to deep breathing while bouncing on a large ball in the arms of an adult. Additional light chest compressions and inhalations may be given. A physiotherapist will perform the intervention at least once daily, and the parents will be manually guided and receive written information about how to change body positions of their child regularly in a similar way throughout the hospital stay.
Interventions
Comparing two experimental interventions with standard care
Eligibility Criteria
You may qualify if:
- Infants hospitalized because of respiratory infections such as bronchiolitis, pneumonia or other airway obstructions.
- Age 0-24 months
- Born in gestation week 35 or later.
- Guardians understand written Swedish, English, Arabic or Persian
You may not qualify if:
- Previous cardiac or respiratory disease
- hospitalized more than 24 hours on this occasion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (2)
Skåne University Hospital
Malmo, SE 20502, Sweden
Centrallasarettet
Vaxjo, 352 34, Sweden
Related Publications (2)
Andersson-Marforio S, Lundkvist Josenby A, Hansen C, Ekvall Hansson E. 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. Pilot Feasibility Stud. 2022 Mar 30;8(1):76. doi: 10.1186/s40814-022-01030-2.
PMID: 35351205DERIVEDAndersson-Marforio S, Lundkvist Josenby A, Ekvall Hansson E, Hansen C. The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial. Trials. 2020 Sep 21;21(1):803. doi: 10.1186/s13063-020-04681-9.
PMID: 32958026DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Ekvall Hansson, PhD
Lund University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Randomisation is carried out with sealed envelopes that are only opened just before intervention starts. There are different care givers who carry out the observations and who perform the interventions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
July 2, 2018
Study Start
January 23, 2018
Primary Completion
May 31, 2022
Study Completion
December 31, 2022
Last Updated
September 30, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share