Severe PneumoniaNCT07593989
Feasibility and Preliminary Efficacy of a Child Life-Based Breathing Exercise Program for Children Recovering From Severe Pneumonia: A Pilot Randomized Controlled Trial
A study testing routine health education + a Child Life-Based Breathing Exercise Program and routine health education in people with Severe Pneumonia, run by Children's Hospital of Fudan University.
Trial summary
The goal of this pilot randomized controlled trial is to evaluate the feasibility and preliminary efficacy of a child life-based breathing exercise program for children recovering from severe pneumonia. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Severe Pneumonia
- What is being tested?
- routine health education + a Child Life-Based Breathing Exercise Program and routine health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6-18 years.
- Diagnosed with severe pneumonia and in the recovery phase.
- Written informed consent is obtained from caregivers, and assent is obtained from children when appropriate.
Who cannot join
- Contraindications to breathing exercise, including: (a) hemodynamic instability (e.g., bradycardia or tachycardia, arrhythmia, hypotension or hypertension); (b) open sternal incision; (c) extracorporeal membrane oxygenation (ECMO); (d) acute phase of severe wheezing or stridor; and (e) severe pulmonary hypertension.
- Communication disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this pilot randomized controlled trial is to evaluate the feasibility and preliminary efficacy of a child life-based breathing exercise program for children recovering from severe pneumonia. The main questions it aims to answer are:
- Is the child life-based breathing exercise program feasible for hospitalized children recovering from severe pneumonia?
- Can the program improve caregiver satisfaction and promote recovery in children with severe pneumonia?
Read more
Researchers will compare a child life-based breathing exercise program combined with routine health education with routine health education alone to determine whether the intervention improves rehabilitation outcomes.
Participants will:
- Receive either routine health education alone or routine health education combined with the child life-based breathing exercise program
- Participate in breathing exercise training during hospitalization
- Complete assessments of caregiver satisfaction and clinical recovery outcomes, including improvement in chest imaging findings and time to resolution of symptoms such as cough, fever, and dyspnea.
- Conditions
- Severe Pneumonia
- Being tested
- routine health education + a Child Life-Based Breathing Exercise Program, routine health education
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine health education + a Child Life-Based Breathing Exercise ProgramBehavioural
In addition to routine health education, participants in the intervention group received a one-to-one respiratory training program based on a child life approach, delivered by the researcher.
routine health educationBehavioural
(1) information on common causes, typical symptoms, disease stages, and risk factors of severe pneumonia; (2) basic knowledge regarding commonly used treatments, such as anti-infective therapy, oxygen therapy, and nebulization, as well as home observation strategies; (3) dietary guidance emphasizing light and easily digestible foods, adequate hydration, and nutritional support while avoiding overly sweet, greasy, or cold foods; and (4) education on body temperature monitoring, recognition of abnormal respiratory symptoms, basic airway clearance care, and maintenance of appropriate indoor temperature, humidity, and ventilation.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | In control group, participants received routine health education. Receives: Behavioral: routine health education |
| intervention group | Experimental | In addition to routine health education, participants in the intervention group received a one-to-one respiratory training program based on a child life approach, delivered by the researcher. Receives: Behavioral: routine health education + a Child Life-Based Breathing Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Satisfaction
Caregiver satisfaction will be assessed 1 day before discharge using a 5-point Likert scale.
Measured: 1 day before discharge
Secondary outcomes (3)
The resolution times of major symptoms and signs
The resolution times of major symptoms and signs, including cough, fever, and dyspnea, will be evaluated and recorded by the attending physicians according to clinical diagnostic and treatment criteria.
Measured: Periprocedural
Improvement in chest imaging findings
Improvement in chest imaging findings will be tracked through the hospital information system throughout hospitalization and after discharge.
Measured: Periprocedural
Completion rate
Proportion of participants completing the intervention
Measured: within 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593989
- Sponsor's protocol ID
- CHFudanU0508
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a Child Life-Based Breathing Exercise Program for Children Recovering From Severe Pneumonia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07593989
- Acronym / sponsor ID
- CHFudanU0508
- Conditions
- Severe Pneumonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 May 2026 (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 this pilot randomized controlled trial is to evaluate the feasibility and preliminary efficacy of a child life-based breathing exercise program for children recovering from severe pneumonia. The main questions it aims to answer are:
- Is the child life-based breathing exercise program feasible for hospitalized children recovering from severe pneumonia?
- Can the program improve caregiver satisfaction and promote recovery in children with severe pneumonia?
Researchers will compare a child life-based breathing exercise program combined with routine health education with routine health education alone to determine whether the intervention improves rehabilitation outcomes.
Participants will:
- Receive either routine health education alone or routine health education combined with the child life-based breathing exercise program
- Participate in breathing exercise training during hospitalization
- Complete assessments of caregiver satisfaction and clinical recovery outcomes, including improvement in chest imaging findings and time to resolution of symptoms such as cough, fever, and dyspnea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: routine health educationIn control group, participants received routine health education. |
| intervention group | Experimental | Behavioral: routine health education + a Child Life-Based Breathing Exercise ProgramIn addition to routine health education, participants in the intervention group received a one-to-one respiratory training program based on a child life approach, delivered by the researcher. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 6-18 years.
- Diagnosed with severe pneumonia and in the recovery phase.
- Written informed consent is obtained from caregivers, and assent is obtained from children when appropriate.
Key exclusion criteria (2 listed)
- Contraindications to breathing exercise, including: (a) hemodynamic instability (e.g., bradycardia or tachycardia, arrhythmia, hypotension or hypertension); (b) open sternal incision; (c) extracorporeal membrane oxygenation (ECMO); (d) acute phase of severe wheezing or stridor; and (e) severe pulmonary hypertension.
- Communication disorders.
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 |
|---|---|---|
| routine health education + a Child Life-Based Breathing Exercise ProgramIn addition to routine health education, participants in the intervention group received a one-to-one respiratory training program based on a child life approach, delivered by the researcher. | Behavioural | intervention group |
| routine health education(1) information on common causes, typical symptoms, disease stages, and risk factors of severe pneumonia; (2) basic knowledge regarding commonly used treatments, such as anti-infective therapy, oxygen therapy, and nebulization, as well as home observation strategies; (3) dietary guidance emphasizing light and easily digestible foods, adequate hydration, and nutritional support while avoiding overly sweet, greasy, or cold foods; and (4) education on body temperature monitoring, recognition of abnormal respiratory symptoms, basic airway clearance care, and maintenance of appropriate indoor temperature, humidity, and ventilation. | Behavioural | control group |
Primary outcome
Caregiver Satisfaction
Time frame: 1 day before discharge
Caregiver satisfaction will be assessed 1 day before discharge using a 5-point Likert scale.
3 secondary outcomes
The resolution times of major symptoms and signs
Time frame: Periprocedural
Improvement in chest imaging findings
Time frame: Periprocedural
Completion rate
Time frame: within 10 minutes after intervention
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 18 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing routine health education + a Child Life-Based Breathing Exercise Program and routine health education in people with Severe Pneumonia, run by Children's Hospital of Fudan University.
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 3 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Xinyi Rong (+86 18217121721, rongxinyi0208@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Satisfaction (time frame: 1 day before discharge). 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 18 May 2026.