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

NCT ID: NCT00751959

Last Updated: 2012-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-06-30

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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Continuous positive airway pressure (CPAP); extremely preterm infant; Idiopathic respiratory distress syndrome (IRDS); Surfactant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

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

Group Type: ACTIVE_COMPARATOR

Curosurf

Intervention Type: DRUG

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

1

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

Group Type: EXPERIMENTAL

Curosurf

Intervention Type: DRUG

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

Interventions

Curosurf

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

Intervention Type: DRUG

Curosurf

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 26 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: collaborator

Altona Children's Hospital

OTHER

Sponsor Role: collaborator

Ruhr University of Bochum

OTHER

Sponsor Role: collaborator

Vestische Kinder- und Jugendklinik Datteln

UNKNOWN

Sponsor Role: collaborator

Hospital of Leverkusen

UNKNOWN

Sponsor Role: collaborator

Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl

UNKNOWN

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Klinikum Aschaffenburg-Alzenau

OTHER

Sponsor Role: collaborator

Asklepios Kliniken Hamburg GmbH

OTHER

Sponsor Role: collaborator

Klinikum Stuttgart

OTHER

Sponsor Role: collaborator

DRK Kinderklinik Siegen

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

The Clinical Trials Centre Cologne

OTHER

Sponsor Role: collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Angela Kribs

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Kribs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, Clinic for Paediatrics

Locations

Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin

Aschaffenburg, , Germany

Charité

Berlin, , Germany

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

Bochum, , Germany

University Hospital, Dept. of Neonatology

Bonn, , Germany

Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl

Cologne, , Germany

University of Cologne, Clinic for Paediatrics

Cologne, , Germany

Vestische Kinder- und Jugendklinik

Datteln, , Germany

University Hospital, Clinic for Paediatrics

Düsseldorf, , Germany

Asklepios Klinik Barmbek

Hamburg, , Germany

Hospital of Leverkusen, Dept. of Children's Medicine

Leverkusen, , Germany

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

Lübeck, , Germany

DRK Kinderklinik

Siegen, , Germany

Klinikum Stuttgart, Olgahospital

Stuttgart, , Germany

Countries

Germany

Other Identifiers

ISRCTN64011614

Identifier Type: REGISTRY

Identifier Source: secondary_id

Uni-Koeln-439

Identifier Type: -

Identifier Source: org_study_id