NCT00751959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

September 11, 2008

Last Update Submit

July 18, 2012

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Continuous positive airway pressure (CPAP)extremely preterm infantIdiopathic respiratory distress syndrome (IRDS)Surfactant

Outcome Measures

Primary Outcomes (1)

  • Survival until term without CLD

    13-17 weeks after birth

Secondary Outcomes (1)

  • Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery

    13-17 weeks after birth

Study Arms (2)

2

ACTIVE COMPARATOR

Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application

Drug: Curosurf

1

EXPERIMENTAL

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

Drug: Curosurf

Interventions

CurosurfDRUG

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

1

Eligibility Criteria

Age23 Weeks - 26 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Primary cardio- pulmonary resuscitation
  • Prenatally diagnosed severe malformation
  • No parental consent
  • Participation in another interventional trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin

Aschaffenburg, D-63739, Germany

Location

Charité

Berlin, D-13353, Germany

Location

Ruhr University of Bochum, Children's Hospital St. Josef Spital

Bochum, D-44791, Germany

Location

University Hospital, Dept. of Neonatology

Bonn, D-53113, Germany

Location

Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl

Cologne, 50735, Germany

Location

University of Cologne, Clinic for Paediatrics

Cologne, D-50937, Germany

Location

Vestische Kinder- und Jugendklinik

Datteln, D-45711, Germany

Location

University Hospital, Clinic for Paediatrics

Düsseldorf, D-40225, Germany

Location

Asklepios Klinik Barmbek

Hamburg, D-22291, Germany

Location

Hospital of Leverkusen, Dept. of Children's Medicine

Leverkusen, D-51375, Germany

Location

University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine

Lübeck, D-23538, Germany

Location

DRK Kinderklinik

Siegen, D-57072, Germany

Location

Klinikum Stuttgart, Olgahospital

Stuttgart, D-70196, Germany

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPulmonary Atelectasis

Interventions

poractant alfa

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Angela Kribs, MD

    University of Cologne, Clinic for Paediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations

DE(13)