Positioning of Children With Acute Respiratory Insufficiency

NCT07170085 | Recruiting

• 1 other identifier: HCA-PC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Disease

Keywords

positioning

Outcome Measures

Primary Outcomes (2)

• 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

  one hour

• respiratory rate

  respiration per minute

  1 hour

Secondary Outcomes (3)

• saturation

  1 hour

• pulse

  1 hour

• apneas

  1 hour

Study Arms (2)

supine-prone

EXPERIMENTAL

first supine position, then prone position

Other: positioning

prone-supine

EXPERIMENTAL

first prone position, then supine position

Other: positioning

Interventions

positioning OTHER

The children will be positioned in the supine and prone position

prone-supine; supine-prone

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Hans Christian Andersen´s Childrens Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• The Research Unit Hans Christian Andersn Children´s Hospital

  Odense University Hospital

  STUDY CHAIR

Central Study Contacts

Josefine Gradman, MD, PhD

CONTACT

+4529241375; josefine.gradman@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)