Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
- Registration Number
- NCT00751959
- Lead Sponsor
- University of Cologne
- Brief Summary
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
- Detailed Description
80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3
- Postnatal age of more than 10 min. and less than 2 hours
- Gestational age ≥ 23+0 and < 27+0
- Primary cardio- pulmonary resuscitation
- Prenatally diagnosed severe malformation
- No parental consent
- Participation in another interventional trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Curosurf Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application 1 Curosurf Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
- Primary Outcome Measures
Name Time Method Survival until term without CLD 13-17 weeks after birth
- Secondary Outcome Measures
Name Time Method Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery 13-17 weeks after birth
Trial Locations
- Locations (13)
Klinikum Stuttgart, Olgahospital
🇩🇪Stuttgart, Germany
DRK Kinderklinik
🇩🇪Siegen, Germany
Ruhr University of Bochum, Children's Hospital St. Josef Spital
🇩🇪Bochum, Germany
University of Cologne, Clinic for Paediatrics
🇩🇪Cologne, Germany
Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin
🇩🇪Aschaffenburg, Germany
Charité
🇩🇪Berlin, Germany
Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
🇩🇪Cologne, Germany
Hospital of Leverkusen, Dept. of Children's Medicine
🇩🇪Leverkusen, Germany
Vestische Kinder- und Jugendklinik
🇩🇪Datteln, Germany
University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine
🇩🇪Lübeck, Germany
University Hospital, Dept. of Neonatology
🇩🇪Bonn, Germany
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
University Hospital, Clinic for Paediatrics
🇩🇪Duesseldorf, Germany