Eine randomisierte kontrollierte Studie zum Vergleich einer prophylaktischen mit einer selektiven wenig invasiven Surfactant Therapie bei FrühgeborenenEine multizentrische Phase IV Studie.

Phase 1

Conditions: Respiratory distress syndrome of premature infants
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2021-005495-19-DE

Lead Sponsor: niversity Hospital Schleswig-Holstein

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 698

Inclusion Criteria

Gestational age at birth 25 weeks + 0 days to 28 weeks + 6 days
Age <= 60 minutes
Supplemental oxygen <=30% on continous positive airway pressure
Parental consent (exception: emergency situation)
Are the trial subjects under 18? yes
Number of subjects for this age range: 698
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lethal malformations or lethal conditions.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We here propose to test prophylactic treatment with LISA within the first hour of life (intervention group) compared to a selective treatment with surfactant (via LISA or via an endotracheal tube) if supplemental oxygen requirement exceeds 30% or respiratory distress is worsening (control group). The primary endpoint of the trial is forced expiratory volume within one second (FEV1) at 5 years of age.;Secondary Objective: To study the long term effects of prophylactic surfactant treatment on lung function and general health of preterm infants.;Primary end point(s): Forced expiratory volume within one second (FEV1) z-score calculated according to Global Lung Function Initiative (GLI) standards.;Timepoint(s) of evaluation of this end point: At age 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Forced vital capacity (FVC), FEV1/FVC, running distance within 3 minutes, obstructive bronchitis within the last 12 months, cerebral pals, movement battery for children score, IQ (WPPSI IV).;Timepoint(s) of evaluation of this end point: At age 5 years