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

• ClinicalTrials.gov Identifier: NCT00751959
• Recruitment Status: Completed
• First Posted: September 12, 2008
• Last Update Posted: July 19, 2012
• Sponsor: University of Cologne
• 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

Tracking Information

• First Submitted Date: September 11, 2008
• First Posted Date: September 12, 2008
• Last Update Posted Date: July 19, 2012
• Study Start Date: April 2009
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 11, 2008): Survival until term without CLD [ Time Frame: 13-17 weeks after birth ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 11, 2008): Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery [ Time Frame: 13-17 weeks after birth ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
• Official Title: Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Respiratory Distress Syndrome, Newborn

Intervention

• Drug: Curosurf
  Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
• Drug: Curosurf
  Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application

Study Arms

• Active Comparator: 2
  Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
  Intervention: Drug: Curosurf
• Experimental: 1
  Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
  Intervention: Drug: Curosurf

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 18, 2012): 213
• Original Estimated Enrollment (submitted: September 11, 2008): 180
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Weeks to 26 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00751959
• Other Study ID Numbers: Uni-Koeln-439; ISRCTN64011614 ( Registry Identifier: ISRCTN )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Angela Kribs, University of Cologne
• Original Responsible Party: Dr. med. Angela Kribs, University of Cologne, Clinic for Paediatrics
• Current Study Sponsor: University of Cologne
• Original Study Sponsor: Same as current

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

Investigators

• Principal Investigator: Angela Kribs, MD; University of Cologne, Clinic for Paediatrics

• PRS Account: University of Cologne
• Verification Date: July 2012