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

NCT00751959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2012-07-19

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

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

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    collaborator OTHER
  • Altona Children's Hospital

    collaborator OTHER
  • Ruhr University of Bochum

    collaborator OTHER
  • Vestische Kinder- und Jugendklinik Datteln

    collaborator UNKNOWN
  • Hospital of Leverkusen

    collaborator UNKNOWN
  • Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl

    collaborator UNKNOWN
  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER
  • Klinikum Aschaffenburg-Alzenau

    collaborator OTHER
  • Asklepios Kliniken Hamburg GmbH

    collaborator OTHER
  • Klinikum Stuttgart

    collaborator OTHER
  • DRK Kinderklinik Siegen

    collaborator UNKNOWN
  • University Hospital, Bonn

    collaborator OTHER
  • Charite University, Berlin, Germany

    collaborator OTHER
  • The Clinical Trials Centre Cologne

    collaborator OTHER
  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV
  • University of Cologne

    lead OTHER

Principal Investigators

  • Angela Kribs, MD · University of Cologne, Clinic for Paediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
26 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751959 on ClinicalTrials.gov