Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
NCT00751959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213
Last updated 2012-07-19
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.
Conditions
- Respiratory Distress Syndrome, Newborn
Interventions
- DRUG
-
Curosurf
Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
- DRUG
-
Curosurf
Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
Sponsors & Collaborators
-
University Hospital Schleswig-Holstein
collaborator OTHER -
Altona Children's Hospital
collaborator OTHER -
Ruhr University of Bochum
collaborator OTHER -
Vestische Kinder- und Jugendklinik Datteln
collaborator UNKNOWN -
Hospital of Leverkusen
collaborator UNKNOWN -
Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
collaborator UNKNOWN -
Heinrich-Heine University, Duesseldorf
collaborator OTHER -
Klinikum Aschaffenburg-Alzenau
collaborator OTHER -
Asklepios Kliniken Hamburg GmbH
collaborator OTHER -
Klinikum Stuttgart
collaborator OTHER -
DRK Kinderklinik Siegen
collaborator UNKNOWN -
University Hospital, Bonn
collaborator OTHER -
Charite University, Berlin, Germany
collaborator OTHER -
The Clinical Trials Centre Cologne
collaborator OTHER -
German Federal Ministry of Education and Research
collaborator OTHER_GOV -
University of Cologne
lead OTHER
Principal Investigators
-
Angela Kribs, MD · University of Cologne, Clinic for Paediatrics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 23 Weeks
- Max Age
- 26 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- Germany
Study Locations
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