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Physiotherapy for Infants With Bronchiolities

Primary Purpose

Infant Conditions, Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Non-individualized
Individualized
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant Conditions focused on measuring Infant, Respiration

Eligibility Criteria

0 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skåne University HospitalRecruiting
  • CentrallasarettetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

Non-individualized

Individualized

Arm Description

The infants will receive the standard care at the ward.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

oxygen saturation
Change in percutanous oxygen saturation measured by probe on the foot
respiratory rate
Change in manually counted RR during one minute
Heart rate
Change in pulse oximeter
General condition, parents' assessment
Time to the first reduction in Numeric Rating Scale 0-10, (0 the best, 10 the worst)
Lung complications
Referral to an intensive care unit

Full Information

First Posted
October 13, 2017
Last Updated
September 24, 2021
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03575091
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Conditions, Respiratory Insufficiency
Keywords
Infant, Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of tree parallel groups, 1 control and 2 intervention groups.
Masking
Investigator
Masking Description
Randomisation is carried out with sealed envelopes that are only opened just before intervention starts. There are different care givers who carry out the observations and who perform the interventions.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
The infants will receive the standard care at the ward.
Arm Title
Non-individualized
Arm Type
Experimental
Arm Description
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.
Arm Title
Individualized
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Non-individualized
Intervention Description
Comparing two experimental interventions with standard care
Intervention Type
Other
Intervention Name(s)
Individualized
Intervention Description
Comparing two experimental interventions with standard care
Primary Outcome Measure Information:
Title
Time to improvement
Description
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
Time Frame
Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
Secondary Outcome Measure Information:
Title
oxygen saturation
Description
Change in percutanous oxygen saturation measured by probe on the foot
Time Frame
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Title
respiratory rate
Description
Change in manually counted RR during one minute
Time Frame
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Title
Heart rate
Description
Change in pulse oximeter
Time Frame
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Title
General condition, parents' assessment
Description
Time to the first reduction in Numeric Rating Scale 0-10, (0 the best, 10 the worst)
Time Frame
Baseline and every third hour up to discharge from hospital, no more than two weeks
Title
Lung complications
Description
Referral to an intensive care unit
Time Frame
At discharge from the ward, no more than two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Andersson Marforio, MSc
Phone
+46768092399
Email
sonja.andersson_marforio@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Ekvall Hansson, PhD
Phone
+46462221986
Email
eva.ekvall-hansson@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ekvall Hansson, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Malmö
ZIP/Postal Code
SE 20502
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Andersson Marforio, MSc
Phone
+4646178404
Email
sonja.andersson_marforio@med.lu.se
Facility Name
Centrallasarettet
City
Växjö
ZIP/Postal Code
352 34
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Andersson Marforio, MSc
Email
sonja.andersson_marforio@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35351205
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. Erratum In: Pilot Feasibility Stud. 2022 May 19;8(1):104.
Results Reference
derived
PubMed Identifier
32958026
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.
Results Reference
derived

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Physiotherapy for Infants With Bronchiolities

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