A randomised controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (pro.LISA)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Universitaetsklinikum Schleswig-Holstein AöR
- Enrollment
- 698
- Locations
- 23
- Primary Endpoint
- Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in premature infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years. The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in preterm infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years.
Investigators
Prof. Dr. Wolfgang Göpel
Scientific
Universitaetsklinikum Schleswig-Holstein AöR
Eligibility Criteria
Inclusion Criteria
- •Preterm infants with a gestational age of 25+0 to 30+6 weeks of pregnancy
- •Age <= 60 minutes
- •Spontaneous breathing on CPAP
- •Pulse oximetrically measured saturation >=90% with a FiO2 <= 30%
- •Written informed consent of the legal guardian(s) (retrospectively if necessary)
Exclusion Criteria
- •Malformations or diseases with a probable lethal outcome
- •Hypersensitivity to surfactant, sodium hydrogen carbonate or sodium chloride
Outcomes
Primary Outcomes
Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
Secondary Outcomes
- At the age of 5 years: (1) FVC z-score, (2) FEV1/FVC z-score, (3) walking distance in the 3-minute walk test, (4) obstructive bronchitis treated with medication in the last 12 months, (5) cerebral palsy, defined as Gross Motor Function Classification System values > 1, (6) values in the Movement Assessment Battery for Children score, (7) intelligence quotient, determined with the WPPSI IV