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

This study has been completed.
Sponsor:
Collaborators:
University Hospital Schleswig-Holstein - Lübeck Campus
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
Asklepios Kliniken Hamburg GmbH
Klinikum Stuttgart
DRK Kinderklinik Siegen
University Hospital, Bonn
Charite University, Berlin, Germany
Clinical Trials Center Cologne
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Angela Kribs, University of Cologne
ClinicalTrials.gov Identifier:
NCT00751959
First received: September 11, 2008
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention
Respiratory Distress Syndrome, Newborn
Drug: Curosurf

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Survival until term without CLD [ Time Frame: 13-17 weeks after birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery [ Time Frame: 13-17 weeks after birth ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   23 Weeks to 26 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751959

Locations
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 - Lübeck Campus
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
Asklepios Kliniken Hamburg GmbH
Klinikum Stuttgart
DRK Kinderklinik Siegen
University Hospital, Bonn
Charite University, Berlin, Germany
Clinical Trials Center Cologne
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Angela Kribs, MD University of Cologne, Clinic for Paediatrics
  More Information

No publications provided

Responsible Party: Angela Kribs, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT00751959     History of Changes
Other Study ID Numbers: Uni-Koeln-439, ISRCTN64011614
Study First Received: September 11, 2008
Last Updated: July 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Continuous positive airway pressure (CPAP)
extremely preterm infant
Idiopathic respiratory distress syndrome (IRDS)
Surfactant

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014