Clinical trial NCT03575091: Physiotherapy for Infants With Bronchiolities
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Conditions
Respiratory Insufficiency
Keywords: Infant
Respiration
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of tree parallel groups, 1 control and 2 intervention groups.
Primary purpose: TREATMENT

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.

Detailed description: All children under 2 years of age who are admitted to the hospital for a respiratory infection and who have previously been essentially healthy are asked to participate. The infants will be randomized to 3 groups, 1 control group and 2 intervention groups. The infants in the control group will receive the standard care at the clinic. In one intervention group the parents will receive instructions how to vary their child body position regularly, and in the other intervention group the child will receive physiotherapy regularly and the parents will carry out some treatment. Further actions in the form of inhalations or stimulation of deep breathing, will be used when needed. The children will be observed following a structured observational protocol regularly throughout the hospital stay.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous cardiac or respiratory disease
* hospitalized more than 24 hours on this occasion

Primary outcomes:
measure: Time to improvement
timeFrame: Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
Secondary outcomes:
measure: oxygen saturation
timeFrame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
measure: respiratory rate
timeFrame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
measure: Heart rate
timeFrame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
measure: General condition, parents' assessment
timeFrame: Baseline and every third hour up to discharge from hospital, no more than two weeks
measure: Lung complications
timeFrame: At discharge from the ward, no more than two weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Växjö
country: Sweden
facility: Centrallasarettet
Study officials:
affiliation: Lund University
name: Eva Ekvall Hansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Andersson-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.