Clinical trial • Respiratory
PHOSPHOLIPID FRACTION, BOVINE LUNG for Respiratory distress syndrome in preterm infants
Clinical trial of PHOSPHOLIPID FRACTION, BOVINE LUNG for Respiratory distress syndrome in preterm infants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Respiratory distress syndrome in preterm infants
- Drug Modality
- Other
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 17-07-2024
- First CTIS Authorization Date
- 31-07-2024
Trial design
Randomised, prophylactic less invasive surfactant administration (lisa) versus selective lisa (control); no drug doses or schedules specified in the record. trial across 26 sites in Germany.
- Randomised
- Yes
- Comparator
- Prophylactic Less Invasive Surfactant Administration (LISA) versus selective LISA (control); no drug doses or schedules specified in the record.
- Target Sample Size
- 578
- Trial Duration For Participant
- 1825
Eligibility
Recruits 578 paediatric patients.
- Vulnerable Population
- The trial population is preterm infants (vulnerable population). Consent is provided by the legal guardian(s); the protocol states: "Written informed consent of the legal guardian(s) (retrospectively if necessary)". Subject information and informed consent form documents (including delayed-consent versions) are provided in multiple languages (German, English, Turkish, Arabic, Ukrainian) according to the documents listed.
Inclusion criteria
- {"criterion_text":"- Preterm infants with a gestational age of 25+0 to 30+6 weeks of pregnancy\n- Age <= 60 minutes\n- Spontaneous breathing on CPAP\n- Pulse oximetrically measured saturation >=90% with a FiO2 <= 30%\n- Written informed consent of the legal guardian(s) (retrospectively if necessary)"}
Exclusion criteria
- {"criterion_text":"- Malformations or diseases with a probable lethal outcome\n- Hypersensitivity to surfactant, sodium hydrogen carbonate or sodium chloride"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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).","definition_or_measurement_approach":"FEV1 measured at 5 years of age reported as Global Lung Function Initiative z-score."}
Secondary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Multiple outcomes assessed at age 5 years: spirometric z-scores (FVC, FEV1/FVC), 3-minute walk test distance, clinical outcomes (medication-treated obstructive bronchitis in past 12 months), cerebral palsy defined by GMFCS >1, Movement Assessment Battery for Children score, and IQ by WPPSI IV."}
Recruitment
- Planned Sample Size
- 578
- Recruitment Window Months
- 89
- Consent Approach
- Written informed consent is obtained from the legal guardian(s); the protocol allows retrospective (delayed) consent if necessary: "Written informed consent of the legal guardian(s) (retrospectively if necessary)". Subject information and consent forms (including delayed consent versions) are available in multiple languages (German, English, Turkish, Arabic, Ukrainian) as per provided ICF documents.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 578
Germany
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 595
- Number Of Sites
- 26
- Number Of Participants
- 578
Sites
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Kristin Weinert
- Principal Investigator Email
- kristin.weinert@med.ovgu.de
- Contact Person Name
- Kristin Weinert
- Contact Person Email
- kristin.weinert@med.ovgu.de
- Site Name
- Christophorus Kliniken Coesfeld
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Anna Siemes
- Principal Investigator Email
- anna.siemes@christophorus-kliniken.de
- Contact Person Name
- Anna Siemes
- Contact Person Email
- anna.siemes@christophorus-kliniken.de
- Site Name
- Universität Witten/Herdecke - Vestische Kinder- und Jugendklinik Datteln
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Sirma Supcun-Ritzler
- Principal Investigator Email
- s.supcun@kinderklinik-datteln.de
- Contact Person Name
- Sirma Supcun-Ritzler
- Contact Person Email
- s.supcun@kinderklinik-datteln.de
- Site Name
- Universitätsmedizin Göttingen
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Jana Dieks
- Principal Investigator Email
- Jana.Dieks@med.uni-goettingen.de
- Contact Person Name
- Jana Dieks
- Contact Person Email
- Jana.Dieks@med.uni-goettingen.de
- Site Name
- Universitätsmedizin Greifswald
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Matthias Heckmann
- Principal Investigator Email
- matthias.heckmann@uni-greifswald.de
- Contact Person Name
- Matthias Heckmann
- Contact Person Email
- matthias.heckmann@uni-greifswald.de
- Site Name
- GFO Kliniken Bonn, Betriebsstätte St. Marien-Hospital
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Katja Schneider
- Principal Investigator Email
- Katja.Schneider@gfo-kliniken-bonn.de
- Contact Person Name
- Katja Schneider
- Contact Person Email
- Katja.Schneider@gfo-kliniken-bonn.de
- Site Name
- Evangelisches Klinikum Bethel gGmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Ursula Weller
- Principal Investigator Email
- Ursula.Weller@evkb.de
- Contact Person Name
- Ursula Weller
- Contact Person Email
- Ursula.Weller@evkb.de
- Site Name
- Helios Klinikum Hildesheim GmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Levente Bejo
- Principal Investigator Email
- Levente.Bejo@helios-gesundheit.de
- Contact Person Name
- Levente Bejo
- Contact Person Email
- Levente.Bejo@helios-gesundheit.de
- Site Name
- KJF Klinik Augsburg, Klinik für Kinder und Jugendliche
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Thomas Völkl
- Principal Investigator Email
- Voelkl.Thomas@josefinum.de
- Contact Person Name
- Thomas Völkl
- Contact Person Email
- Voelkl.Thomas@josefinum.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Wolfgang Göpel
- Principal Investigator Email
- wolfgang.goepel@uksh.de
- Contact Person Name
- Wolfgang Göpel
- Contact Person Email
- wolfgang.goepel@uksh.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Clinic for Paediatrics and Adolescent Medicine
- Principal Investigator Name
- Mirjam Jung
- Principal Investigator Email
- Mirjam.Jung@uk-gm.de
- Contact Person Name
- Mirjam Jung
- Contact Person Email
- Mirjam.Jung@uk-gm.de
- Site Name
- Klinikum Itzehoe
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Georg Hillebrand
- Principal Investigator Email
- g.hillebrand@kh-itzehoe.de
- Contact Person Name
- Georg Hillebrand
- Contact Person Email
- g.hillebrand@kh-itzehoe.de
- Site Name
- St. Vincenz-Krankenhaus
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Frank Dohle
- Principal Investigator Email
- F.Dohle@vincenz.de
- Contact Person Name
- Frank Dohle
- Contact Person Email
- F.Dohle@vincenz.de
- Site Name
- Universitätsklinikum Tübingen
- Department Name
- Center for Pediatric Clinical Studies
- Principal Investigator Name
- Axel Franz
- Principal Investigator Email
- axel.franz@med.uni-tuebingen.de
- Contact Person Name
- Axel Franz
- Contact Person Email
- axel.franz@med.uni-tuebingen.de
- Site Name
- Universitätsklinikum Düsseldorf
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Mark Dzietko
- Principal Investigator Email
- Mark.Dzietko@med.uni-duesseldorf.de
- Contact Person Name
- Mark Dzietko
- Contact Person Email
- Mark.Dzietko@med.uni-duesseldorf.de
- Site Name
- Klinik Hallerwiese-Cnopfsche Kinderklinik
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Michael Schroth
- Principal Investigator Email
- cnopf.neonatologie@diakoneo.de
- Contact Person Name
- Michael Schroth
- Contact Person Email
- cnopf.neonatologie@diakoneo.de
- Site Name
- Bürgerhospital Frankfurt am Main – Clementine Kinderhospital
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Moritz Wolff
- Principal Investigator Email
- m.wolff@buergerhospital-ffm.de
- Contact Person Name
- Moritz Wolff
- Contact Person Email
- m.wolff@buergerhospital-ffm.de
- Site Name
- Universitätsklinikum Freiburg
- Department Name
- Center for Pediatric Clinical Studies
- Principal Investigator Name
- Hans Fuchs
- Principal Investigator Email
- hans.fuchs@uniklinik-freiburg.de
- Contact Person Name
- Hans Fuchs
- Contact Person Email
- hans.fuchs@uniklinik-freiburg.de
- Site Name
- Klinikum der Universität zu Köln
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Angela Kribs
- Principal Investigator Email
- kinderklinik-studiensekretariat@uk-koeln.de
- Contact Person Name
- Angela Kribs
- Contact Person Email
- kinderklinik-studiensekretariat@uk-koeln.de
- Site Name
- Klinikverbund Allgaeu gGmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Oliver Jens Götz
- Principal Investigator Email
- Oliver.Goetz@klinikverbund-allgaeu.de
- Contact Person Name
- Oliver Jens Götz
- Contact Person Email
- Oliver.Goetz@klinikverbund-allgaeu.de
- Site Name
- Klinikum Bremen-Mitte gGmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Thorsten Körner
- Principal Investigator Email
- Thorsten.Koerner@klinikum-bremen-ldw.de
- Contact Person Name
- Thorsten Körner
- Contact Person Email
- Thorsten.Koerner@klinikum-bremen-ldw.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Susanne Schmidtke
- Principal Investigator Email
- su.schmidtke@asklepios.com
- Contact Person Name
- Susanne Schmidtke
- Contact Person Email
- su.schmidtke@asklepios.com
- Site Name
- Universitätsklinikum Würzburg
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Christoph Härtel
- Principal Investigator Email
- Haertel_C1@ukw.de
- Contact Person Name
- Christoph Härtel
- Contact Person Email
- Haertel_C1@ukw.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Lisa Schröder
- Principal Investigator Email
- lisa.schroeder@vivantes.de
- Contact Person Name
- Lisa Schröder
- Contact Person Email
- lisa.schroeder@vivantes.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Hagen Bayer
- Principal Investigator Email
- hagen.bayer@vivantes.de
- Contact Person Name
- Hagen Bayer
- Contact Person Email
- hagen.bayer@vivantes.de
- Site Name
- Universitätsklinikum Essen
- Department Name
- Paediatric clinic
- Principal Investigator Name
- Anja Stein
- Principal Investigator Email
- Anja.stein@uk-essen.de
- Contact Person Name
- Anja Stein
- Contact Person Email
- Anja.stein@uk-essen.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- ALVEOFACT® 45 mg/ml 54 mg, Pulver und Lösungsmittel zur Herstellung einer Suspension
- Active Substance
- PHOSPHOLIPID FRACTION, BOVINE LUNG
- Modality
- Other
- Routes Of Administration
- ENDOTRACHEOPULMONARY USE
- Route
- ENDOTRACHEOPULMONARY USE
- Authorisation Status
- Authorised
- Maximum Dose
- 200 mg/kg (max daily); max total 100 mg/kg
- Investigational Product Name
- Curosurf® 120 mg Suspension zur endotracheopulmonalen Instillation
- Active Substance
- PORACTANT ALFA
- Modality
- Other
- Routes Of Administration
- ENDOTRACHEOPULMONARY USE
- Route
- ENDOTRACHEOPULMONARY USE
- Authorisation Status
- Authorised
- Maximum Dose
- 200 mg/kg (max daily); max total 100 mg/kg
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