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A randomised controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (pro.LISA)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516504-42-00
Acronym
pro.LISA_01_21
Enrollment
578
Registered
2024-07-31
Start date
2022-03-05
Completion date
Unknown
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory distress syndrome in preterm infants

Brief summary

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).

Detailed description

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

Interventions

Sponsors

Universitaetsklinikum Schleswig-Holstein AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026