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

Phase 3

Recruiting

• Conditions: Respiratory distress syndrome in preterm infants

• Registration Number: 2024-516504-42-00
• Lead Sponsor: Universitaetsklinikum Schleswig-Holstein AöR

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-31
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 698

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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		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

Trial Locations

Locations (23)

Bürgerhospital Frankfurt am Main – Clementine Kinderhospital; 🇩🇪 Frankfurt am Main, Germany

Universitaetsklinikum Schleswig-Holstein AöR; 🇩🇪 Luebeck, Germany

Klinik Hallerwiese-Cnopfsche Kinderklinik; 🇩🇪 Nürnberg, Germany

St. Vincenz-Krankenhaus; 🇩🇪 Paderborn, Germany

Klinikum der Universität zu Köln; 🇩🇪 Köln, Germany

KJF Klinik Augsburg, Klinik für Kinder und Jugendliche; 🇩🇪 Augsburg, Germany

Evangelisches Klinikum Bethel gGmbH; 🇩🇪 Bielefeld, Germany

Universitaetsklinikum Magdeburg AöR; 🇩🇪 Magdeburg, Germany

Klinikum Bremen-Mitte gGmbH; 🇩🇪 Bremen, Germany

Klinikum Itzehoe; 🇩🇪 Itzehoe, Germany

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Bürgerhospital Frankfurt am Main – Clementine Kinderhospital

🇩🇪Frankfurt am Main, Germany

Moritz Wolff

Site contact

+496915001764

m.wolff@buergerhospital-ffm.de