Surfactant Or Not

Phase 1

Active, not recruiting

• Conditions: Respiratory distress in neonates born at 34 to 38+6 weeks of gestation; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2019-003764-45-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-19
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1522

Inclusion Criteria

1. Born at 34+0–38+6 weeks of gestation
2. = 24 hours old
3. Respiratory distress defined as:
-FiO2 = 0.3 and < 0.45 needed to maintain SaO2 = 92%, or
-Clinically significant work of breathing, regardless of FiO2
4. Clinical decision to provide non-invasive respiratory support
5. Written parental informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 1522
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Major structural or chromosomal abnormality
2. No realistic prospect of survival
3. Prior intubation and/or surfactant administration
4. Known or suspected hypoxic ischaemic encephalopathy
5. Congenital abnormality of the upper or lower respiratory tract
6. Known or suspected neuromuscular disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified