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NCT Number: NCT03976895

Prone Position in Acute Bronchiolitis

Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support.

Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU.

In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis.

Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.

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Key information

Conditions

Acute Viral Bronchiolitis Bronchial Diseases Bronchiolitis Bronchiolitis, Viral Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon, Bron, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infant under 6 months
  • Hospitalized in critical care unit (continuous monitoring unit or intensive care unit)
  • With a clinical diagnosis of acute viral bronchiolitis (criterion of the American Academy of Pediatrics 2014)
  • m-WCAS score ≥ 3 and / or hypercapnic acidosis with pH <7.35 and pCO2> 50mmHg (6.7 kPa)
  • Informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file (with deferred written consent).

Exclusion criteria

  • Infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with pH <7.25 without ventilatory support and/or hypoxia with impossibility of maintaining SpO2> 92% whatever the FiO2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder)
  • Patient already positioned in the prone position before randomization for more than 3 hours
  • Significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), Ear Nose and Throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease.
  • Contraindication to Prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy
  • Patient who is not affiliated (or does not benefit from) to a national social security system

Treatment and study plan

Supine position (SP)

Procedure

Infants under high flow nasal cannula (HFNC) will be positioned in the supine position.

Patients may be positioned temporarily in lateral position between periods of supine position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis.

Prone position (PP)

Procedure

Infants under high flow nasal cannula (HFNC) will be placed in the prone position during at least 24 hours over the first 48 hours. The positioning will be standardized (chest on the bed plan and abdomen cleared) and children should be placed in the prone position immediately after randomization.

Patients may be positioned temporarily in lateral position between periods of prone position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis.

Primary outcomes

  1. Proportion of ventilated children in each of the 2 groups

    Time frame: 3 days

    Indications for the use of ventilation (invasive or non-invasive ventilation) will be standardized in both groups (based on the interregional protocol for the management of bronchiolitis):

    • Clinical aggravation defined by an increase ≥ 1 point of the m-WCAS score
    • Persistence of hypercapnic acidosis with pH ≤7.30 and pCO2≥ 8 kPa or FiO2> 60% under HFNC at 2 L/kg/min
    • More than 3 significant apneas per hour (apnea with desaturation <90% and / or bradycardia <90 / min)
    • Consciousness disorder

    Anytime over the first 3 days after inclusion

Secondary outcomes

  1. Proportion of failure

    Time frame: 3 days

    Failure is defined as:

    • HFNC failure (composite failure criterion validated by an independent committee)
    • worsening of mWCAS score ≥ 1 point
    • hypercapnic acidosis (pH ≤7.30 and pCO2≥8kPa)
    • significant apnea (apnea with desaturation <90% and / or bradycardia <90/min)

    Anytime over the first 3 days after inclusion

  2. Causes of failure

    Time frame: 3 days

    Failure is defined as:

    • HFNC failure (composite failure criterion validated by an independent committee)
    • worsening of mWCAS score ≥ 1 point
    • hypercapnic acidosis (pH ≤7.30 and pCO2≥8kPa)
    • significant apnea (apnea with desaturation <90% and / or bradycardia <90/min)

    Anytime over the first 3 days after inclusion

  3. Duration of ventilation

    Time frame: maximum 3 months

    Duration of ventilation (high flow nasal cannula, invasive, non-invasive) in hours.

    This data will be collected at critical care unit discharge.

  4. Length of stay

    Time frame: maximum 3 months

    Length of stay in days. This data will be collected at hospital discharge.

  5. Oxygenation evaluation

    Time frame: 2 hours

    Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.

  6. Oxygenation evaluation

    Time frame: 12 hours

    Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.

  7. Oxygenation evaluation

    Time frame: 24 hours

    Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.

  8. Tolerance evaluation

    Time frame: maximum 3 months

    Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition.

    This data will be collected at critical care unit discharge.

  9. Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours

    Time frame: 2 hours

    Scale ranges to 0 from 15 and is a combination of criteria:

    • Face: Relaxed=0 to Permanent tightness or prostrate face,frozen or purple face=3
    • Body: Relaxed=0 to Permanent agitation,tightness of extremities and stiffness of limbs or very poor and limited motor skills with fixed body=3
    • Sleep:Easily, extended and calm=0 to No sleep=3
    • Relationship:Smile to the angels,smile answer,attentive to the listening=0 to Refuses contact,no relationship possible,howl or moan without any stimulation=3
    • Comfort: Do not need comfort=0 to Inconsolable,desperate sucking=3

  10. Evaluation of the feasibility of maintaining the position

    Time frame: 48 hours

    Proportion of children in the prone position repositioned definitively in the supine position before performing the cumulative 24 hours of prone position, cumulative hours of prone position in the first 48 hours

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis

Acronym: PROPOSITIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2019
Registry last updated
Jun 25, 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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