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Positioning of Children With Acute Respiratory Insufficiency

NCT07170085 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Disease

Interventions

OTHER

positioning

The children will be positioned in the supine and prone position

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • The Research Unit Hans Christian Andersn Children´s Hospital · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2027-04-01
Completion
2028-04-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170085 on ClinicalTrials.gov