Physiotherapy for Infants With Bronchiolities

Not Applicable

• Conditions: Infant Conditions; Respiratory Insufficiency
• Interventions: Other: Non-individualized; Other: Individualized

• Registration Number: NCT03575091
• Lead Sponsor: Lund University

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.

Study Timeline

• Study First Submitted: 2017-10-13
• Study Start: 2018-01-23
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-30
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-individualized	Non-individualized	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.
Individualized	Individualized	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.

Primary Outcome Measures

Name	Time	Method
Time to improvement	Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Skåne University Hospital; 🇸🇪 Malmö, Sweden

Centrallasarettet; 🇸🇪 Växjö, Sweden