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    Summary
    EudraCT Number:2015-001654-15
    Sponsor's Protocol Code Number:NL53018.015.15
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-25
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-001654-15
    A.3Full title of the trial
    Intrauterine resuscitation during term labor by maternal hyperoxygenation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The treatment of suspected fetal hypoxia during labor by administration of additional oxygen to the mother.
    A.3.2Name or abbreviated title of the trial where available
    INTEREST-O2
    A.4.1Sponsor's protocol code numberNL53018.015.15
    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 SponsorMáxima Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportStichting de Weijerhorst
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMáxima Medisch Centrum
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressHazenloop 8
    B.5.3.2Town/ cityEindhoven
    B.5.3.3Post code5646 BA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031624225377
    B.5.5Fax number0031408889564
    B.5.6E-maillaurenbullens@gmail.com
    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.2.1.1.1Trade name Medicinal oxygen In Dutch: Zuurstof medicinaal gasvormig SOL 100 % v/v medicinaal gas, samengeperst
    D.2.1.1.2Name of the Marketing Authorisation holderSOL SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.1Product nameMedicinal oxygen
    D.3.2Product code RVG 30866
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Fetal distress during the second stage of labor.
    E.1.1.1Medical condition in easily understood language
    Fetal distress during the final stage of labor (when the woman is bearing down).
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective: the primary objective is to investigate the effect of maternal hyperoxygenation with 100% oxygen on fetal heart rate pattern. We will describe the difference in FHR deceleration depth, duration and frequency, baseline and variability 10 minutes before and after maternal oxygen administration.
    E.2.2Secondary objectives of the trial
    Secondary Objectives: venous and arterial umbilical cord blood gas analysis (pH, lactate, base excess, pO2 and pCO2), Apgar-score, fECG, mode of delivery, NICU-admissions and markers for free oxygen radical production (8-isoprostane, hypoxanthine and malondialdehyde) and catecholamines in venous and arterial umbilical cord blood, and maternal complaints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Maternal factors:
    - Age > 18 years
    - In term labor (gestational age 37+0 - 41+6 weeks)
    - Intention for vaginal delivery
    - Ability to understand the Dutch language
    - Informed consent obtained

    Fetal factors:
    - Singleton fetus
    - Fetus in head position
    - Suspected fetal distress (Suboptimal or Abnormal CTG according to the FIGO guideline)
    E.4Principal exclusion criteria
    Maternal factors:
    - Age < 18 years
    - Use of any of the following medication: corticosteroids, antihypertensives, magnesiumsulphate, amiodaron, opioids, amiodaron, adriamycine, bleomycine, actinomycine, menadion, (chloor-) promazine, thiordiazine, chloroquine
    - Pre-existing cardiac disease
    - Pulmonary disease needing the use of medication
    - Diabetes
    - Hyperthyroidism
    - Anemia (Hb < 6.5 mmol/l)
    - Smoking, using alcohol or recreational drugs during pregnancy
    - Pre- or postterm labor (< 37+0 or > 41+6 weeks)
    - Planned caesarean section

    Fetal factors:
    - Multiple fetuses
    - Suspected growth restriction (<p10)
    - Suspected infection
    - Congenital malformations
    - Breech position
    E.5 End points
    E.5.1Primary end point(s)
    Fetal heart rate pattern: frequency, depth and duration of decelerations, variability and baseline will be determined before and after oxygen administration. The frequency of decelerations and FHR baseline will be determined manually. Variability and deceleration depth and duration will be determined by a computer program (MatLab). The outcome for deceleration depth and duration will be determined by calculation the area under the curve of each deceleration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For study purposes, the cardiotocogram (including fetal heart rate tracing) will be stored in a computer and analysed when all subjects are included in the study.
    E.5.2Secondary end point(s)
    - Umbilical cord pH (arterial and venous), base excess, lactate, pO2 and pCO2
    - Apgar score
    - Mode of delivery
    - fECG
    - NICU admission
    - Markers for free oxygen radicals in arterial and venous umbilical cord blood
    - Catecholamines in arterial and venous umbilical cord blood
    - Maternal complaints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Umbilical cord blood is taken immediately after birth. Blood gas analyses is performed immediately after birth (commom practice), while markers for free oxygen radical activity and cathecholamines are examined when samples from all patients are taken (these samples will be stored in the meantime).
    Apgar score is given within 10 minutes after birth.
    Mode of delivery, NICU admission, maternal complaints and baseline characteristics (for example fetal weight and sex) are noted directly after the delivery.
    f ECG analyses is perfomed when all patients are included in the study (analysis is perfomed on stored FHR tracings).
    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 No
    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) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Depending on the outcome parameter the design is open, or the investigator is blinded.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Conventional care, such as tocolysis, stop oxytocin infusion or maternal repositioning.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    When the fetus is born and the blood withdrawn from the umbilical cord the study has finished for this specific participant. The other outcome parameters to be determined afterwards are conventional care. The subject does not have to come back for check ups afterwards.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    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) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    None.
    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 Decision2015-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
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