Respiratory distress syndrom of preterm infants (ICD 10: P22.0)
Conditions
Interventions
Product Name: Surfactant
Product Code: Curosurf, Survanta, Alveofact
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: Surfactant
CAS Number: 8000050284
Current S
Sponsors
Universitätsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gestational age 26+0 - 28+6 (weeks+days) Birth-weight below 1500 grams Age 0-12 hours Written informed consent of parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Lethal malformations Participation in another therapeutic trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is, to demonstrate that the treatment of spontaneously breathing very-low-birth-weight infants (birth weight below 1500 grams) with intratracheal instillation of surfactant is able to reduce the frequency of mechanical ventilation.;Secondary Objective: Secondary objectives of the study are to demonstrate that the proposed procedure ·is associated with a reduced duration and intensity of mechanical ventilation ·is associated with a reduced incidence of bronchopulmonary dysplasia ·while being at least equivalent to standard treatment with regard to the secondary outcome measures death, intraventricular hemorrhage grade III and IV (IVH), periventricular leukomalacia (PVL) ;Primary end point(s): Mechanical ventilation or inspiratory oxygen above 60% for more than 2 hours (to to keep oxygen saturation above 85%) or pCO2 above 65 mmHg for more than two hours. The time period within the primary endpoint could be reached is defined as the 25. until the 72. hour of life. | — |
Countries
Germany
Outcome results
None listed