Status:
COMPLETED
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Altona Children's Hospital
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
23-26 years
Phase:
NA
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 o...
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Primary cardio- pulmonary resuscitation
- Prenatally diagnosed severe malformation
- No parental consent
- Participation in another interventional trial
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00751959
Start Date
April 1 2009
End Date
June 1 2012
Last Update
July 19 2012
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin
Aschaffenburg, Germany, D-63739
2
Charité
Berlin, Germany, D-13353
3
Ruhr University of Bochum, Children's Hospital St. Josef Spital
Bochum, Germany, D-44791
4
University Hospital, Dept. of Neonatology
Bonn, Germany, D-53113