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NCT Number: NCT07170085

Positioning of Children With Acute Respiratory Insufficiency

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.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hans Christian Andersen´s Childrens Hospital

Odense, 5000, Denmark

Location status: Recruiting

Location contact

Josefine Gradman, MD, PhD

CONTACT

[email protected]

+4529241375

Josefine Gradman, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positioning

Other

The children will be positioned in the supine and prone position

Primary outcomes

  1. 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

  2. respiratory rate

    Time frame: 1 hour

    respiration per minute

Secondary outcomes

  1. saturation

    Time frame: 1 hour

    percent

  2. pulse

    Time frame: 1 hour

    hearth rate

  3. apneas

    Time frame: 1 hour

    Number of apneas >10 seconds

Study contacts

Contact information is provided by the study sponsor or research team.

Josefine Gradman, MD, PhD

CONTACT

[email protected]

+4529241375

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 12, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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