Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks (NINSAPP)
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ClinicalTrials.gov Identifier: NCT00751959 |
Recruitment Status :
Completed
First Posted : September 12, 2008
Last Update Posted : July 19, 2012
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Condition or disease | Intervention/treatment | Phase |
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Respiratory Distress Syndrome, Newborn | Drug: Curosurf | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 213 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2
Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
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Drug: Curosurf
Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application |
Experimental: 1
Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
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Drug: Curosurf
Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP |
- Survival until term without CLD [ Time Frame: 13-17 weeks after birth ]
- Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery [ Time Frame: 13-17 weeks after birth ]

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Ages Eligible for Study: | 23 Weeks to 26 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- Primary cardio- pulmonary resuscitation
- Prenatally diagnosed severe malformation
- No parental consent
- Participation in another interventional trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751959
Germany | |
Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin | |
Aschaffenburg, Germany, D-63739 | |
Charité | |
Berlin, Germany, D-13353 | |
Ruhr University of Bochum, Children's Hospital St. Josef Spital | |
Bochum, Germany, D-44791 | |
University Hospital, Dept. of Neonatology | |
Bonn, Germany, D-53113 | |
Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl | |
Cologne, Germany, 50735 | |
University of Cologne, Clinic for Paediatrics | |
Cologne, Germany, D-50937 | |
Vestische Kinder- und Jugendklinik | |
Datteln, Germany, D-45711 | |
University Hospital, Clinic for Paediatrics | |
Duesseldorf, Germany, D-40225 | |
Asklepios Klinik Barmbek | |
Hamburg, Germany, D-22291 | |
Hospital of Leverkusen, Dept. of Children's Medicine | |
Leverkusen, Germany, D-51375 | |
University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine | |
Lübeck, Germany, D-23538 | |
DRK Kinderklinik | |
Siegen, Germany, D-57072 | |
Klinikum Stuttgart, Olgahospital | |
Stuttgart, Germany, D-70196 |
Principal Investigator: | Angela Kribs, MD | University of Cologne, Clinic for Paediatrics |
Responsible Party: | Angela Kribs, MD, University of Cologne |
ClinicalTrials.gov Identifier: | NCT00751959 |
Other Study ID Numbers: |
Uni-Koeln-439 ISRCTN64011614 ( Registry Identifier: ISRCTN ) |
First Posted: | September 12, 2008 Key Record Dates |
Last Update Posted: | July 19, 2012 |
Last Verified: | July 2012 |
Continuous positive airway pressure (CPAP) extremely preterm infant Idiopathic respiratory distress syndrome (IRDS) Surfactant |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Lung Diseases Respiratory Tract Diseases Respiration Disorders |
Infant, Premature, Diseases Infant, Newborn, Diseases Poractant alfa Pulmonary Surfactants Respiratory System Agents |