BronchiolitisNCT06862895
Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis
A study testing chest physiotherapy in people with Bronchiolitis and Infant, Newborn, Diseases, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician The main questions aims to answer: Does chest physiotherapy improve clinical outcomes of infants… Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Bronchiolitis, Infant, Newborn, Diseases, Chest Physiotherapy
- What is being tested?
- chest physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.
Who cannot join
- Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)
- Children who intubated and admitted to Intensive Care Unit (ICU).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Hawler Medical University
Erbil, Kurdistan, 61002
Nazar R Othman, Assist.Prof, 750 494 6398 ext. +964, nazar.othman@hmu.edu.krd
About this study
Official title: Effect of Chest Physiotherapy Educational Program on Mother's Knowledge, Practice and Clinical Outcomes of Infants With Bronchiolitis
The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician
The main questions aims to answer:
- Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?
- Does educational program improve mothers knowledge and practice regarding chest physiotherapy?
Researcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days
- Being tested
- chest physiotherapy
- Medical subject headings
- Bronchiolitis, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest physiotherapyOther
Chest Physiotherapy is including various techniques, in this study classical CPT was used to be applied to participants
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | chest physiotherapy Receives: Other: chest physiotherapy |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Clinical Outcomes of Infants with Bronchiolitis
changing of oxygen saturation( SPO2) <90% to normal level SPO2>92%
Measured: baseline
change in physiological outcomes of Infants with Bronchiolitis
change in respiratory rate from abnormal to normal (0-3 month RR:35-55 3-6 month RR:30-45 6-12 month RR:25-40) breath per minute
Measured: baseline
Secondary outcomes (2)
Improvement in Knowledge of Mother's
after application of educational program expected to to improve mother's knowledge regarding chest physiotherapy
Measured: After 3 days
Improvement in practices of Mother's
after application of educational program expected to to improve mother's practice regarding chest physiotherapy
Measured: After 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jan 2025
- Primary completion1 Feb 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shwan, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862895
- Sponsor's protocol ID
- CPT
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chest Physiotherapy Educational Program on Mother's Knowledge, Practice and Clinical Outcomes of Infants With Bronchiolitis
- ClinicalTrials.gov ID
- NCT06862895
- Acronym / sponsor ID
- CPT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 6 Mar 2025 (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.
The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician
The main questions aims to answer:
- Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?
- Does educational program improve mothers knowledge and practice regarding chest physiotherapy?
Researcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: chest physiotherapychest physiotherapy |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.
Key exclusion criteria (2 listed)
- Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)
- Children who intubated and admitted to Intensive Care Unit (ICU).
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 |
|---|---|---|
| chest physiotherapyChest Physiotherapy is including various techniques, in this study classical CPT was used to be applied to participants | Other | intervention group |
Primary outcome
change in Clinical Outcomes of Infants with Bronchiolitis
Time frame: baseline
changing of oxygen saturation( SPO2) <90% to normal level SPO2>92%
change in physiological outcomes of Infants with Bronchiolitis
Time frame: baseline
change in respiratory rate from abnormal to normal (0-3 month RR:35-55 3-6 month RR:30-45 6-12 month RR:25-40) breath per minute
2 secondary outcomes
Improvement in Knowledge of Mother's
Time frame: After 3 days
Improvement in practices of Mother's
Time frame: After 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest physiotherapy in people with Bronchiolitis and Infant, Newborn, Diseases, run by Hawler Medical University at 1 site in Iraq.
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 1 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazar Othman, Assist.Prof (750 494 6398 ext. +964, nazar.othman@hmu.edu.krd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Clinical Outcomes of Infants with Bronchiolitis (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.