The bronchiolitis endotracheal surfactant study

Phase 2

• Conditions: Mechanical ventilation in infants with bronchiolitis; Respiratory

• Registration Number: ISRCTN11746266
• Lead Sponsor: niversity of Liverpool

Brief Summary

2024 Other publications in https://doi.org/10.1136/bmjopen-2023-077023 A mixed-method embedded study (added 04/01/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Last Update Posted: 6 May 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

1. Term-born infants < 26 weeks old and preterm-born infants < 26 weeks corrected age†
2. Diagnosis of bronchiolitis (see below)
3. Requires conventional invasive MV via tracheal intubation
4. Parent or person with parental responsibility has given written informed consent for trial participation
†Premature born infants have their age corrected to account for weeks of lost gestation

Exclusion Criteria

1. Major congenital anomalies, including complex or haemodynamically compromising cardiac anomalies.
2. Congenital neuromuscular disease
3. Already intubated for MV for > 48 hours or likely to have been intubated for MV for > 48 hours by randomisation
4. Have received or are receiving extracorporeal membrane oxygenation (ECMO) or oscillation during this episode of bronchiolitis
5. Have received or are receiving intratracheal administration of any surfactant during this episode of bronchiolitis
6. Receiving MV for primary apnoea rather than respiratory failure
7. A decision to wean to extubation has already been made
8. Clinical judgement of futility

Study & Design

• Study Type: Interventional
• Study Design: Not specified