A RANDOMIZED CONTROLLED STUDY TO EVALUATE THE EFFICACY OF A SUPPLEMENTAL DOSE OF CUROSURF IN PRE-TERM INFANTS ON MECHANICAL VENTILATION FOR RESPIRATORY DISTRESS SYNDROME RDS IN PREVENTING EXTUBATION FAILURE - ND

• Conditions: RDS - preterm infants; MedDRA version: 6.1Level: PTClassification code 10028974

• Registration Number: EUCTR2005-005371-15-IT
• Lead Sponsor: CHIESI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

BW between 500 and 1500 g. In-born and out-born male or female pre term neonates. Diagnosis of RDS and treatment with either prophylactic or rescue Curosurf maximum of 2 doses . Endotracheally intubated at 3 days, with planned extubation between 72 and 240 hours of age. No potentially life threatening conditions unrelated to immaturity. Written informed parental consent for their infant to take part in the study see Appendix II .
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Patients will be excluded from this study if they meet ANY of the following criteria American Pediatric Gross Assessment Record score below 3 at 5 minutes of age. Delivered by mothers with rupture of the membranes for more than 3 weeks. Known genetic or chromosomal disorders. Receiving nitric oxide. Major conditions of prematurity which can affect respiratory drive or respiratory outcomes, already present before extubation, such as o pulmonary hemorrhage or intracranial bleeding of grade 3 or higher, o necrotising enterocolitis NEC , o patent ductus arteriosus PDA , o clinically severe infection. NOTE PDA and clinically severe infection are contra indications to extubation. Participation in another clinical study of any placebo, drug, biological, or device conducted under the provision of a protocol.

Study & Design

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