RDS - preterm infants MedDRA version: 6.1 Level: PT Classification code 10028974
Conditions
Interventions
Trade Name: CUROSURF 1 FL 1,5ML 80 MG/ML
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: Natural phospholipids
CAS Number: 129069-19-8
Concentration unit: mg mi
Sponsors
CHIESI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and tolerability of an additional dose of Curosurf;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is the proportion of pre-term infants who experience extubation failures, | — |
Countries
Italy
Outcome results
None listed