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Positioning of Children With Acute Respiratory Insufficiency

Positioning of Children With Acute Respiratory Insufficiency

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07170085
Enrollment
40
Registered
2025-09-12
Start date
2025-11-24
Completion date
2028-04-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Disease

Keywords

positioning

Brief 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 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.

Interventions

The children will be positioned in the supine and prone position

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

Inclusion criteria

* Age 0-12 months * Clinical respiratory infection * Physician-ordered High-Flow oxygen or CPAP * Consent from the legal guardian

Exclusion criteria

* Significant chronic pulmonary, cardiac, or neurological disorders * Children admitted to intensive care

Design outcomes

Primary

MeasureTime frameDescription
m-WCASone hourModified 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 rate1 hourrespiration per minute

Secondary

MeasureTime frameDescription
saturation1 hourpercent
pulse1 hourhearth rate
apneas1 hourNumber of apneas \>10 seconds

Countries

Denmark

Contacts

CONTACTJosefine Gradman, MD, PhD
josefine.gradman@rsyd.dk+4529241375
STUDY_CHAIRThe Research Unit Hans Christian Andersn Children´s Hospital

Odense University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026