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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency; Infant Conditions
• Intervention / Treatment: Other: Non-individualized; Other: Individualized

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonja Andersson Marforio, MSc; Phone Number: +46768092399; Email: sonja.andersson_marforio@med.lu.se
• Study Contact Backup: Name: Eva Ekvall Hansson, PhD; Phone Number: +46462221986; Email: eva.ekvall-hansson@med.lu.se

Study Locations

• Sweden
  • Malmö, Sweden, SE 20502
    • Recruiting
    • Skane University Hospital
    • Contact: Sonja Andersson Marforio, MSc; Phone Number: +4646178404; Email: sonja.andersson_marforio@med.lu.se
  • Växjö, Sweden, 352 34
    • Recruiting
    • Centrallasarettet
    • Contact: Sonja Andersson Marforio, MSc; Email: sonja.andersson_marforio@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lund University

Publications and helpful links

General Publications

• 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. Erratum in: Pilot Feasibility Stud. 2022 May 19;8(1):104.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Infant; Respiration
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2017/190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No