Status:
COMPLETED
Feasibility Study - Neofact
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Klinikum Stuttgart
Conditions:
Respiratory Distress Syndrome in Premature Infant
Surfactant Deficiency Syndrome Neonatal
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant in...
Eligibility Criteria
Inclusion
- Preterm infants with respiratory distress syndrome and the need for Surfactant administration (oxygen requirement with FiO2 ≥ 30% and/or mod. Silverman Andersen Respiratory Severity Score (RSS) ≥ 5)
- Respiratory support with non-invasive CPAP at the time of Surfactant administration
Exclusion
- Preterms with an gestational age \< 26+0 weeks
- Preterms with malformations of the respiratory tract
- Clinical decision on intubation / surfactant application via endotracheal tube e.g. because of respiratory drive disorder
- (Missing parental consent)
- (Attending physician is not delegated by the principal investigator)
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04086095
Start Date
May 13 2019
End Date
October 31 2019
Last Update
November 5 2019
Active Locations (2)
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1
Klinikum Stuttgart - Olgahospital
Stuttgart, Baden-Wurttemberg, Germany, 70176
2
University Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076