Acute Respiratory DiseaseNCT07170085
Positioning of Children With Acute Respiratory Insufficiency
A study testing positioning in people with Acute Respiratory Disease, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Acute Respiratory Disease
- What is being tested?
- positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Nov 2025to 1 Apr 2028
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-12 months
- Clinical respiratory infection
- Physician-ordered High-Flow oxygen or CPAP
- Consent from the legal guardian
Who cannot join
- Significant chronic pulmonary, cardiac, or neurological disorders
- Children admitted to intensive care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hans Christian Andersen´s Childrens Hospital
Odense, 5000
Josefine Gradman, MD, PhD, +4529241375, josefine.gradman@rsyd.dk
Josefine Gradman, MD, PhD
About this study
Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy.
In adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency.
Read more
The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.
The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child.
The Study Itself:
Once the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.
Read the detailed description
The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.
Hypothesis:
Children under 1 year of age with acute respiratory insufficiency undergoing CPAP or High-Flow oxygen therapy will have improved respiratory function when positioned in the prone position compared to the supine position, as assessed by respiratory rate and symptom score.
The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen.
. Method: The study is designed as an open-label, randomized crossover study. The intervention involves positioning: 1 hour in the prone position and 1 hour in the supine position while the child receives treatment with CPAP or High-Flow oxygen.
The study will enroll children hospitalized with infection-triggered acute respiratory insufficiency, who, based on a clinical physician's assessment, are indicated for treatment with either CPAP or High-Flow oxygen. They will be randomized to either prone positioning followed by supine positioning or supine positioning followed by prone positioning upon initiation of respiratory support.
- Conditions
- Acute Respiratory Disease
- Being tested
- positioning
- Keywords
- positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positioningOther
The children will be positioned in the supine and prone position
| Study group | Role | What they receive |
|---|---|---|
| supine-prone | Experimental | first supine position, then prone position Receives: Other: positioning |
| prone-supine | Experimental | first prone position, then supine position Receives: Other: positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
m-WCAS
Modified Wood's Clinical Asthma Score (mWCAS) a combined score of saturation, inspiratory wheezes, expiratory wheezes, retractions, general condition, each scored 1-4, with 1 being the best and 4 being the worst
Measured: one hour
respiratory rate
respiration per minute
Measured: 1 hour
Secondary outcomes (3)
saturation
percent
Measured: 1 hour
pulse
hearth rate
Measured: 1 hour
apneas
Number of apneas >10 seconds
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start24 Nov 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- The Research Unit Hans Christian Andersn Children´s Hospital, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170085
- Sponsor's protocol ID
- HCA-PC
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning of Children With Acute Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT07170085
- Acronym / sponsor ID
- HCA-PC
- Conditions
- Acute Respiratory Disease
- Keywords
- positioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 12 Sep 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.
Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy.
In adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency.
The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.
The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child.
The Study Itself:
Once the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.
Detailed description
The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.
Hypothesis:
Children under 1 year of age with acute respiratory insufficiency undergoing CPAP or High-Flow oxygen therapy will have improved respiratory function when positioned in the prone position compared to the supine position, as assessed by respiratory rate and symptom score.
The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen.
. Method: The study is designed as an open-label, randomized crossover study. The intervention involves positioning: 1 hour in the prone position and 1 hour in the supine position while the child receives treatment with CPAP or High-Flow oxygen.
The study will enroll children hospitalized with infection-triggered acute respiratory insufficiency, who, based on a clinical physician's assessment, are indicated for treatment with either CPAP or High-Flow oxygen. They will be randomized to either prone positioning followed by supine positioning or supine positioning followed by prone positioning upon initiation of respiratory support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine-prone | Experimental | Other: positioningfirst supine position, then prone position |
| prone-supine | Experimental | Other: positioningfirst prone position, then supine position |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 0-12 months
- Clinical respiratory infection
- Physician-ordered High-Flow oxygen or CPAP
- Consent from the legal guardian
Key exclusion criteria (2 listed)
- Significant chronic pulmonary, cardiac, or neurological disorders
- Children admitted to intensive care
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 |
|---|---|---|
| positioningThe children will be positioned in the supine and prone position | Other | prone-supine, supine-prone |
Primary outcome
m-WCAS
Time frame: one hour
Modified Wood's Clinical Asthma Score (mWCAS) a combined score of saturation, inspiratory wheezes, expiratory wheezes, retractions, general condition, each scored 1-4, with 1 being the best and 4 being the worst
respiratory rate
Time frame: 1 hour
respiration per minute
3 secondary outcomes
saturation
Time frame: 1 hour
pulse
Time frame: 1 hour
apneas
Time frame: 1 hour
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 23 Apr 2026.
- 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.
The Research Unit Hans Christian Andersn Children´s Hospital study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positioning in people with Acute Respiratory Disease, run by Odense University Hospital at 1 site in Denmark.
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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 Denmark. 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 Josefine Gradman, MD, PhD (+4529241375, josefine.gradman@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
m-WCAS (time frame: one hour). 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 23 Apr 2026.