EUCTR2008-000896-30-DEActive, not recruitingPhase 1
Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks - NINSAPP
niversity of Cologne0 sites0 target enrollmentStarted: January 15, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Gestational age >= 23+0 and <27+0 weeks
- •2) Postnatal age of more than 10 min and less than 2 hours
- •3) IRDS with Silverman-Score >= 5 and/or FiO2 >= 0.3
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1) Primary cardio-pulmonary resuscitation
- •2) Prenatally diagnosed severe malformation
- •3) No parental consent
- •4) Participation in another interventional trial
Investigators
Similar Trials
Completed
Not Applicable
Surfactant application during spontaneous breathing in premature infants <27 weeksISRCTN64011614niversity of Cologne (Germany)210
Completed
Phase 2
Intratracheal Instillation of Pulmonary Surfactant Combined with Budesonide in Preterm Infants with RDSRespiratory distress syndrome (RDS) requiring surfactantrespiratory distress syndromepreterm infantBronchopulmonary dysplasiaTCTR20220310005Division of Neonatology Ramathibodi Hospital120
Unknown
Phase 4
Surfactant Administration During Spontaneous BreathingPulmonary Interstitial EmphysemaPneumothoraxBronchopulmonary DysplasiaNCT01329432Zekai Tahir Burak Women's Health Research and Education Hospital100
Completed
Not Applicable
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 WeeksRespiratory Distress Syndrome, NewbornNCT00751959University of Cologne213
Recruiting
Not Applicable
Early intratracheal treatment with surfactant plus steroids (SurPluS) in low birth-weight premature infants following preterm premature rupture of the membranes-clincal course and outcomeP23.9P25.1P26.8P28.5P27.1P52.0P52.1P52.2P52.4P36.9P39.9P77P78.0P91.1H35.1Intracerebral (nontraumatic) haemorrhage of fetus and newbornBacterial sepsis of newborn, unspecifiedInfection specific to the perinatal period, unspecifiedCongenital pneumonia, unspecifiedPneumothorax originating in the perinatal periodOther pulmonary haemorrhages originating in the perinatal periodRespiratory failure of newbornBronchopulmonary dysplasia originating in the perinatal periodIntraventricular (nontraumatic) haemorrhage, grade 1, of fetus and newbornIntraventricular (nontraumatic) haemorrhage, grade 2, of fetus and newbornIntraventricular (nontraumatic) haemorrhage, grade 3, and grade 4 of fetus and newbornNecrotizing enterocolitis of fetus and newbornPerinatal intestinal perforationAcquired periventricular cysts of newbornRetinopathy of prematurityDRKS00021504niversität zu Lübeck186