Physiotherapy for Infants With Bronchiolities

Respiratory Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03575091
• Other study ID #: 2017/190
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Lund University
• Contact: Sonja Andersson Marforio, MSc
• Phone: +46768092399
• Email: sonja.andersson_marforio[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Conditions
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• Non-individualized
Comparing two experimental interventions with standard care
• Individualized
Comparing two experimental interventions with standard care

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö
Sweden	Centrallasarettet	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	respiratory rate	Change in manually counted RR during one minute	Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Secondary	Heart rate	Change in pulse oximeter	Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Secondary	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
Secondary	Lung complications	Referral to an intensive care unit	At discharge from the ward, no more than two weeks