Physiotherapy for Infants With Bronchiolities
24. september 2021 opdateret af: Lund University
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sonja Andersson Marforio, MSc
- Telefonnummer: +46768092399
- E-mail: sonja.andersson_marforio@med.lu.se
Undersøgelse Kontakt Backup
- Navn: Eva Ekvall Hansson, PhD
- Telefonnummer: +46462221986
- E-mail: eva.ekvall-hansson@med.lu.se
Studiesteder
-
-
-
Malmö, Sverige, SE 20502
- Rekruttering
- Skane University Hospital
-
Kontakt:
- Sonja Andersson Marforio, MSc
- Telefonnummer: +4646178404
- E-mail: sonja.andersson_marforio@med.lu.se
-
Växjö, Sverige, 352 34
- Rekruttering
- Centrallasarettet
-
Kontakt:
- Sonja Andersson Marforio, MSc
- E-mail: sonja.andersson_marforio@med.lu.se
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 sekund til 2 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: control group
The infants will receive the standard care at the ward.
|
|
|
Eksperimentel: 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.
|
Comparing two experimental interventions with standard care
|
|
Eksperimentel: 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.
|
Comparing two experimental interventions with standard care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to improvement
Tidsramme: 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
|
Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
oxygen saturation
Tidsramme: 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
|
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
|
|
respiratory rate
Tidsramme: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
|
Change in manually counted RR during one minute
|
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
|
|
Heart rate
Tidsramme: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
|
Change in pulse oximeter
|
Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
|
|
General condition, parents' assessment
Tidsramme: 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)
|
Baseline and every third hour up to discharge from hospital, no more than two weeks
|
|
Lung complications
Tidsramme: At discharge from the ward, no more than two weeks
|
Referral to an intensive care unit
|
At discharge from the ward, no more than two weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. januar 2018
Primær færdiggørelse (Forventet)
31. maj 2022
Studieafslutning (Forventet)
31. december 2022
Datoer for studieregistrering
Først indsendt
13. oktober 2017
Først indsendt, der opfyldte QC-kriterier
29. juni 2018
Først opslået (Faktiske)
2. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017/190
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