Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks

Phase 1

• Conditions: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants; MedDRA version: 14.0Level: LLTClassification code 10021735Term: Infant respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2008-000896-30-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-15
• Study Completion: 2012-06-21
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1) Gestational age >= 23+0 and <27+0 weeks
2) Postnatal age of more than 10 min and less than 2 hours
3) IRDS with Silverman-Score >= 5 and/or FiO2 >= 0.3
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Primary cardio-pulmonary resuscitation
2) Prenatally diagnosed severe malformation
3) No parental consent
4) Participation in another interventional trial

Study & Design

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