Infant ConditionsNCT03575091
Physiotherapy for Infants With Bronchiolities
A study testing Non-individualized and Individualized in people with Infant Conditions and Respiratory Insufficiency, run by Lund University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Infant Conditions, Respiratory Insufficiency
- What is being tested?
- Non-individualized and Individualized
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSweden
- Study dates
- 23 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Previous cardiac or respiratory disease
- hospitalized more than 24 hours on this occasion
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Skåne University Hospital
Malmö, SE 20502
Sonja Andersson Marforio, MSc, +4646178404, sonja.andersson_marforio@med.lu.se
- Recruiting
Centrallasarettet
Vaxjo, 352 34
Sonja Andersson Marforio, MSc, sonja.andersson_marforio@med.lu.se
About this study
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
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.
Read the 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.
- Conditions
- Infant Conditions, Respiratory Insufficiency
- Being tested
- Non-individualized, Individualized
- Keywords
- Infant, Respiration
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-individualizedOther
Comparing two experimental interventions with standard care
IndividualizedOther
Comparing two experimental interventions with standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-individualized |
| 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. Receives: Other: Individualized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
Secondary outcomes (5)
oxygen saturation
Change in percutanous oxygen saturation measured by probe on the foot
Measured: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
respiratory rate
Change in manually counted RR during one minute
Measured: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Heart rate
Change in pulse oximeter
Measured: 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)
Measured: Baseline and every third hour up to discharge from hospital, no more than two weeks
Lung complications
Referral to an intensive care unit
Measured: At discharge from the ward, no more than two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start23 Jan 2018
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of tree parallel groups, 1 control and 2 intervention groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ekvall Hansson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575091
- Sponsor's protocol ID
- 2017/190
- Status last verified
- Sep 2021
- First submitted
- 13 Oct 2017
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35351205Andersson-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.
PubMed 32958026
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03575091
- Acronym / sponsor ID
- 2017/190
- Conditions
- Infant Conditions, Respiratory Insufficiency
- Keywords
- Infant, Respiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Comparison of tree parallel groups, 1 control and 2 intervention groups.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The infants will receive the standard care at the ward. |
| Non-individualized | Experimental | Other: Non-individualizedThe 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 | Other: IndividualizedThe 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. |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Previous cardiac or respiratory disease
- hospitalized more than 24 hours on this occasion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-individualizedComparing two experimental interventions with standard care | Other | Non-individualized |
| IndividualizedComparing two experimental interventions with standard care | Other | Individualized |
Primary outcome
Time to improvement
Time frame: 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
5 secondary outcomes
oxygen saturation
Time frame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
respiratory rate
Time frame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Heart rate
Time frame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
General condition, parents' assessment
Time frame: Baseline and every third hour up to discharge from hospital, no more than two weeks
Lung complications
Time frame: At discharge from the ward, no more than two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 35351205Andersson-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.
- Derived from this study: PubMed 32958026Andersson-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ekvall Hansson, PhD principal investigator
Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-individualized and Individualized in people with Infant Conditions and Respiratory Insufficiency, run by Lund University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonja Andersson Marforio, MSc (+46768092399, sonja.andersson_marforio@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to improvement (time frame: Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.