Physiotherapy for Infants With Bronchiolities

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infant Conditions, Respiratory Insufficiency

Intervention / Treatment
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* Other: Non-individualized
* Other: Individualized


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of tree parallel groups, 1 control and 2 intervention groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>The infants will receive the standard care at the ward. | |
| Experimental: Non-individualized<br>The 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. | Other: Non-individualized<br>* Comparing two experimental interventions with standard care<br>|
| Experimental: Individualized<br>The 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. | Other: Individualized<br>* Comparing two experimental interventions with standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen saturation | Change in percutanous oxygen saturation measured by probe on the foot | Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes | 
| respiratory rate | Change in manually counted RR during one minute | Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes | 
| Heart rate | Change in pulse oximeter | Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes | 
| General condition, parents' assessment | Time to the first reduction in Numeric Rating Scale 0-10, (0 the best, 10 the worst) | Baseline and every third hour up to discharge from hospital, no more than two weeks | 
| Lung complications | Referral to an intensive care unit | At discharge from the ward, no more than two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Respiration