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Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks (NINSAPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00751959
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : July 19, 2012
Sponsor:
Collaborators:
University Hospital Schleswig-Holstein
Altona Children's Hospital
Ruhr University of Bochum
Vestische Kinder- und Jugendklinik Datteln
Hospital of Leverkusen
Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
Heinrich-Heine University, Duesseldorf
Klinikum Aschaffenburg-Alzenau
Asklepios Kliniken Hamburg GmbH
Klinikum Stuttgart
DRK Kinderklinik Siegen
University Hospital, Bonn
Charite University, Berlin, Germany
The Clinical Trials Centre Cologne
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Angela Kribs, University of Cologne

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 of less than 27 weeks.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Drug: Curosurf Not Applicable

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 and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

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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
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
Drug: Curosurf
Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP




Primary Outcome Measures :
  1. Survival until term without CLD [ Time Frame: 13-17 weeks after birth ]

Secondary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Cologne
University Hospital Schleswig-Holstein
Altona Children's Hospital
Ruhr University of Bochum
Vestische Kinder- und Jugendklinik Datteln
Hospital of Leverkusen
Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
Heinrich-Heine University, Duesseldorf
Klinikum Aschaffenburg-Alzenau
Asklepios Kliniken Hamburg GmbH
Klinikum Stuttgart
DRK Kinderklinik Siegen
University Hospital, Bonn
Charite University, Berlin, Germany
The Clinical Trials Centre Cologne
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Angela Kribs, MD University of Cologne, Clinic for Paediatrics
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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
Keywords provided by Angela Kribs, University of Cologne:
Continuous positive airway pressure (CPAP)
extremely preterm infant
Idiopathic respiratory distress syndrome (IRDS)
Surfactant
Additional relevant MeSH terms:
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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