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    Summary
    EudraCT Number:2018-000453-41
    Sponsor's Protocol Code Number:BMBF-Fz01KG1602
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2018-03-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-000453-41
    A.3Full title of the trial
    Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety and efficacy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial funded by the German Federal Ministry for Education and Research (BMBF) to evalute the effects of closed-loop automatic control of inspiratory fraction of oxygen in comparison to manual control in extremly preterm infants with respect to complications of prematurity potentially related to inadequate administration of oxygen (ROP, BPD, NEC) and mortality as well as the neurocognitive outcome after 24 months.
    A.3.2Name or abbreviated title of the trial where available
    FiO2-C
    A.4.1Sponsor's protocol code numberBMBF-Fz01KG1602
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03168516
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital Tuebingen
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGerman Federal Ministry for Education and Research (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Pediatric Clinical Studies
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstr. 23
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72070
    B.5.3.4CountryGermany
    B.5.4Telephone number004970712981469
    B.5.5Fax number00497071294857
    B.5.6E-mailfioc@med.uni-tuebingen.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxygen
    D.3.9.3Other descriptive nameOXYGEN PH.EUR.
    D.3.9.4EV Substance CodeSUB172257
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    E.1.1.1Medical condition in easily understood language
    Very premature infants who uniformly suffer from episodes with insufficient oxygen concentrations in their blood (and consecutively insufficient oxygen delivery to their organs).
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10038933
    E.1.2Term Retinopathy of prematurity
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055667
    E.1.2Term Necrotising enterocolitis neonatal
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10011912
    E.1.2Term Death neonatal
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10071101
    E.1.2Term Primary apnoea of premature newborns
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of efficacy of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) provided in standard infant ventilators in addition to manual adjustments of the inspired oxygen fraction (FiO2) during mechanical ventilation, continous positive airway pressure (CPAP) or any other positive pressure respiratory support compared to manual adjustments of the FiO2 only on the primary endpoints.
    E.2.2Secondary objectives of the trial
    To assess the safety of FiO2-C.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Gestational Age at birth 23+0/7 to 27+6/7 weeks
    E.4Principal exclusion criteria
    • Decision not to provide full life support / decision for palliative care only before study entry
    • 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)
    • Postnatal age >48h
    • Missing parental consent
    • Lack of device enabling closed-loop automatic control of FiO2 before randomization
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Composite outcome of death, severe retinopathy of prematurity, chronic lung disease or necrotizing enterocolitis until 36 weeks PMA or (for ROP) until full vascularization of the retina.

    Subordinate co-primary endpoint:
    Composite outcome of death, language/ cognitive delay, motor impairment, severe visual impairment or hearing impairment at 24 months corrected age.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint:
    at a postmenstrual age of 36 weeks for (for the components death, BPD, NEC) and when full retinal vascularisation is reached for ROP

    Subordinate co-primary endpoint:
    the age of 24 months corrected for prematurity
    E.5.2Secondary end point(s)
    Individual components of the primary outcome variables and developmental scores of the Bayley Scales of Infant Development (3rd edition).
    E.5.2.1Timepoint(s) of evaluation of this end point
    at a postmenstrual age of 36 weeks
    at the time when full vascularisation of the retina is reached
    at the age of 24 months corrected for prematurity
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    partially observer-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    The comparator will be routine manual adjustments of FiO2 by bedside nurse and medical staff
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    12 months after LVLS
    Jusitification for delayed "end of study date": our experience in multinational, multicenter trials with limited public funding is, that database entries of follow-up visits are delayed because of incomplete/missing data e.g., due to delegated follow-up examination to external sites (to meet needs of the families involved) etc.. Consequently, database and site closure as well as end of study may be delayed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2340
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 2340
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    newborn infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1850
    F.4.2.2In the whole clinical trial 2340
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment will continue as required by national and international standards of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-29
    P. End of Trial
    P.End of Trial StatusRestarted
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