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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | The infants will receive the standard care at the ward. | |
| Non-individualized | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-individualized | Other | Comparing two experimental interventions with standard care |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Andersson Marforio, MSc | Contact | +46768092399 | sonja.andersson_marforio@med.lu.se | |
| Eva Ekvall Hansson, PhD | Contact | +46462221986 | eva.ekvall-hansson@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Eva Ekvall Hansson, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Recruiting | Malmö | SE 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35351205 | Derived | 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. | |
| 32958026 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057285 | Precision Medicine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Comparison of tree parallel groups, 1 control and 2 intervention groups.
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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.
| Individualized | Other | Comparing two experimental interventions with standard care |
|
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 |
| Centrallasarettet | Recruiting | Vaxjo | 352 34 | Sweden |
|
| 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. |