Clinical trial • Phase III • Other
Oxygen for Extremely preterm birth (gestational age 23+0/7–27+6/7 weeks) | Bronchopulmonary dysplasia | Retinopathy of prematurity | Necrotising enterocolitis | Neonatal death
Phase III trial of Oxygen for Extremely preterm birth (gestational age 23+0/7–27+6/7 weeks) | Bronchopulmonary dysplasia | Retinopathy of prematurity | Ne…
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Extremely preterm birth (gestational age 23+0/7–27+6/7 weeks) | Bronchopulmonary dysplasia | Retinopathy of prematurity | Necrotising enterocolitis | Neonatal death
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 06-08-2024
- First CTIS Authorization Date
- 12-08-2024
Trial design
Randomised, manual adjustments of fio2 only (standard care) compared to closed-loop automatic control of fio2 (fio2-c) Phase III trial across 23 sites in Germany.
- Randomised
- Yes
- Comparator
- Manual adjustments of FiO2 only (standard care) compared to closed-loop automatic control of FiO2 (FiO2-C)
- Target Sample Size
- 865
- Trial Duration For Participant
- 730
Eligibility
Recruits 865 paediatric patients.
- Vulnerable Population
- Preterm infants (neonates) are identified as a vulnerable population; informed consent is handled via subject information and informed consent forms for parents/legal guardians (documents listed: FiO2-C_Elterninformation_V4-3_20210608_clean_public and Einwilligungs-und-Datenschutzerklaerung_V4_3-1-20210608_clean_public). No assent process for participants is described in the available record.
Inclusion criteria
- {"criterion_text":"- GA at birth 23+0/7 to 27+6/7 weeks"}
Exclusion criteria
- {"criterion_text":"- Decision not to provide full life support / decision for palliative care only before study entry\n- Severe congenital abnormalities (particularly those affecting respiratory, cardiovascular, or gastrointestinal function or long-term neuro-cognitive development, whereas a patent ductus arteriosus or a PFO/ASDII is not considered a congenital anomaly in preterm infants)\n- Postnatal age >48h\n- Lack of device enabling closed-loop automatic control of FiO2 before randomization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital","definition_or_measurement_approach":"Composite event occurrence recorded until discharge from hospital; component definitions referenced to protocol sections 7.3.1 (severe ROP), 7.3.2 (physiological definition of BPD) and 7.3.3 (NEC)."}
- {"endpoint_text":"- The primary outcome II is a composite of any of the following: • death or neurodevelopmental impairment (defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)) at 24 months corrected age.","definition_or_measurement_approach":"Composite assessed at 24 months corrected age; neurodevelopmental impairment defined by motor disability (GMFCS 2-5), Bayley Scales of Infant Development (3rd ed.) language or cognitive composite scores <85, or severe visual/hearing impairment (need for hearing aid or cochlear implant)."}
Secondary endpoints
- {"endpoint_text":"- Individual components of the primary outcome variables and developmental scores of the Bayley Scales of Infant Development (3rd edition)","definition_or_measurement_approach":"Assessment of the individual components of the composite endpoints and measurement of developmental outcomes using the Bayley Scales of Infant Development (3rd edition)."}
Recruitment
- Planned Sample Size
- 865
- Recruitment Window Months
- 92
- Consent Approach
- Informed consent obtained from parents/legal guardians as documented by the available subject information and informed consent forms (documents: FiO2-C_Elterninformation_V4-3_20210608_clean_public; Einwilligungs-und-Datenschutzerklaerung_V4_3-1-20210608_clean_public). No participant assent process or languages listed in the available record.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 865
Germany
- Earliest CTIS Part Ii Submission Date
- 06-08-2024
- Latest Decision Or Authorization Date
- 06-08-2025
- Processing Time Days
- 365
- Number Of Sites
- 23
- Number Of Participants
- 865
Sites
- Site Name
- HELIOS Klinikum Erfurt GmbH
- Department Name
- Neonatology
- Principal Investigator Name
- Hans-Joerg Bittrich
- Principal Investigator Email
- hans-joerg.bittrich@helios-kliniken.de
- Contact Person Name
- Hans-Joerg Bittrich
- Contact Person Email
- hans-joerg.bittrich@helios-kliniken.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Neonatology
- Principal Investigator Name
- Patrick Neuberger
- Principal Investigator Email
- P.Neuberger@klinikum-stuttgart.de
- Contact Person Name
- Patrick Neuberger
- Contact Person Email
- P.Neuberger@klinikum-stuttgart.de
- Site Name
- Klinikum St Marien Amberg
- Department Name
- Neonatology
- Principal Investigator Name
- Andreas Fiedler
- Principal Investigator Email
- fiedler.andreas@klinikum-amberg.de
- Contact Person Name
- Andreas Fiedler
- Contact Person Email
- fiedler.andreas@klinikum-amberg.de
- Site Name
- Barmherzige Brueder, Klinik Sankt Hedwig
- Department Name
- Neonatology
- Principal Investigator Name
- Jochen Kittel
- Principal Investigator Email
- jochen.kittel@barmherzige-regensburg.de
- Contact Person Name
- Jochen Kittel
- Contact Person Email
- jochen.kittel@barmherzige-regensburg.de
- Site Name
- Muenchen Klinik gGmbH
- Department Name
- Neonatology
- Principal Investigator Name
- Marcus Krueger
- Principal Investigator Email
- marcus.krueger@klinikum-muenchen.de
- Contact Person Name
- Marcus Krueger
- Contact Person Email
- marcus.krueger@klinikum-muenchen.de
- Site Name
- Diakonissen-Stiftungs-Krankenhaus Speyer gGmbH
- Department Name
- Neonatology
- Principal Investigator Name
- Hans-Juergen Gausepohl
- Principal Investigator Email
- hans-juergen.gausepohl@diakonissen.de
- Contact Person Name
- Hans-Juergen Gausepohl
- Contact Person Email
- hans-juergen.gausepohl@diakonissen.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Neonatology
- Principal Investigator Name
- Julia Sandkoetter
- Principal Investigator Email
- sandkoj@uk.muenster.de
- Contact Person Name
- Julia Sandkoetter
- Contact Person Email
- sandkoj@uk.muenster.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Neonatology
- Principal Investigator Name
- Christian von Schnakenburg
- Principal Investigator Email
- c.schnakenburg@klinikum-esslingen.de
- Contact Person Name
- Christian von Schnakenburg
- Contact Person Email
- c.schnakenburg@klinikum-esslingen.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Neonatology
- Principal Investigator Name
- Thomas Hoehn
- Principal Investigator Email
- thomas.hoehn@uni-duesseldorf.de
- Contact Person Name
- Thomas Hoehn
- Contact Person Email
- thomas.hoehn@uni-duesseldorf.de
- Site Name
- Hannoversche Kinderheilanstalt
- Department Name
- Neonatology
- Principal Investigator Name
- Anna Koluch
- Principal Investigator Email
- koluch@hka.de
- Contact Person Name
- Anna Koluch
- Contact Person Email
- koluch@hka.de
- Site Name
- Kreuznacher Diakonie
- Department Name
- Neonatology
- Principal Investigator Name
- Edmondo Hammond
- Principal Investigator Email
- hammoned@kreuznacherdiakonie.de
- Contact Person Name
- Edmondo Hammond
- Contact Person Email
- hammoned@kreuznacherdiakonie.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Neonatology
- 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
- Klinikum am Steinenberg
- Department Name
- Neonatology
- Principal Investigator Name
- Hans-Christoph Schneider
- Principal Investigator Email
- Schneider_H@klin-rt.de
- Contact Person Name
- Hans-Christoph Schneider
- Contact Person Email
- Schneider_H@klin-rt.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Neonatology
- Principal Investigator Name
- Harald Ehrhardt
- Principal Investigator Email
- harald.ehrhardt@uniklinik-ulm.de
- Contact Person Name
- Harald Ehrhardt
- Contact Person Email
- harald.ehrhardt@uniklinik-ulm.de
- Site Name
- Rems-Murr-Kliniken gGmbH
- Department Name
- Neontology
- Principal Investigator Name
- Ulrich Bernbeck
- Principal Investigator Email
- ulrich.bernbeck@rems-murr-kliniken.de
- Contact Person Name
- Ulrich Bernbeck
- Contact Person Email
- ulrich.bernbeck@rems-murr-kliniken.de
- Site Name
- KJF Klinik Augsburg, Klinik für Kinder und Jugendliche
- Department Name
- Neonatology
- Principal Investigator Name
- Thomas Voelkl
- Principal Investigator Email
- Voelkl.Thomas@josefinum.de
- Contact Person Name
- Thomas Voelkl
- Contact Person Email
- Voelkl.Thomas@josefinum.de
- Site Name
- Gesundheit Nord gGmbH Klinikverbund Bremen
- Department Name
- Neonatology
- Principal Investigator Name
- Thorsten Koerner
- Principal Investigator Email
- Thorsten.Koerner@gesundheitnord.de
- Contact Person Name
- Thorsten Koerner
- Contact Person Email
- Thorsten.Koerner@gesundheitnord.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Neonatology
- Principal Investigator Name
- Barbara Seipolt
- Principal Investigator Email
- Barbara.Seipolt@uniklinikum-dresden.de
- Contact Person Name
- Barbara Seipolt
- Contact Person Email
- Barbara.Seipolt@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Neonatology
- Principal Investigator Name
- Ulrich Thome
- Principal Investigator Email
- ulrich.thome@medizin.uni-leipzig.de
- Contact Person Name
- Ulrich Thome
- Contact Person Email
- ulrich.thome@medizin.uni-leipzig.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Neonatology
- Principal Investigator Name
- Bettina Bohnhorst
- Principal Investigator Email
- bohnhorst.bettina@mh-hannover.de
- Contact Person Name
- Bettina Bohnhorst
- Contact Person Email
- bohnhorst.bettina@mh-hannover.de
- Site Name
- Klinik Hallerwiese - Cnopfsche Kinderklinik
- Department Name
- Neonatology
- Principal Investigator Name
- Michael Schroth
- Principal Investigator Email
- Michael.Schroth@diakoneo.de
- Contact Person Name
- Michael Schroth
- Contact Person Email
- Michael.Schroth@diakoneo.de
- Site Name
- Universitaetsklinikum Freiburg
- Department Name
- Neonatology
- 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
- Perinatalzentrum der LMU München
- Department Name
- Neonatologie
- Principal Investigator Name
- Andreas Flemmer
- Principal Investigator Email
- andreas.flemmer@med.uni-muenchen.de
- Contact Person Name
- Andreas Flemmer
- Contact Person Email
- andreas.flemmer@med.uni-muenchen.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Tuebingen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- OXYGEN PH.EUR.
- Active Substance
- Oxygen
- Modality
- Small molecule
- Routes Of Administration
- Inhalation (INHALATION USE)
- Route
- Inhalation
- Maximum Dose
- 100 % (V/V) percent volume/volume
Related trials
Other published trials that may interest you.