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    Summary
    EudraCT Number:2016-003181-12
    Sponsor's Protocol Code Number:HOTPOT1
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2016-003181-12
    A.3Full title of the trial
    Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can we predict a serious medical condition in the newborn by using an oxygen test, given to the mother when she is undergoing a fetal ultrasound scan
    A.3.2Name or abbreviated title of the trial where available
    HOTPOT
    A.4.1Sponsor's protocol code numberHOTPOT1
    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 SponsorRoyal College of Surgeons in Ireland
    B.1.3.4CountryIreland
    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 supportFriends of the Rotunda
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoyal College of Surgeons in Ireland
    B.5.2Functional name of contact pointRCSI Education & Research Centre
    B.5.3 Address:
    B.5.3.1Street AddressBeaumont Hospital
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD15
    B.5.3.4CountryIreland
    B.5.4Telephone number+353018093789
    B.5.6E-mailinfo@rcsi.ie
    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 Medical Oxygen
    D.2.1.1.2Name of the Marketing Authorisation holderBOC Gases Ireland Limited J F Kennedy Drive Bluebell Dublin 12
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 name99.5 %v/v Medicinal gas, compressed
    D.3.4Pharmaceutical form Inhalation solution
    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.3.9.1CAS number 80937-33-3
    D.3.9.2Current sponsor codeSUB14733MIG
    D.3.9.3Other descriptive nameMedical Oxygen
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number99.5
    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 Yes
    D.3.11.13.1Other medicinal product typeMedicinal gas, compressed
    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
    Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occurs when there is a failure of the normal circulatory transition in the early newborn period. Persistence of the fetal circulation occurs,resulting in pulmonary hypertension,low oxygen levels and marked right-to-left shunting of blood in the newborn heart. Mortality ranges from 4 to 33%.
    E.1.1.1Medical condition in easily understood language
    Persistent pulmonary hypertension of the newborn(PPHN) is a relatively common condition occurring in 7/1000 births.It can cause serious respiratory(breathing)and cardiac(heart)problems in the newborn
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    The primary study objective is to predict the occurrence of neonatal pulmonary hypertension by measuring the pulmonary artery reactivity to maternal hyperoxygenation in fetuses at risk of neonatal respiratory morbidity.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are to:

    1. Assess vasoreactive response to maternal hyperoxygenation (MH) in utero.

    2. Assess the ability of MH to predict the degree of pulmonary vasculopathy present prior to birth.

    3. Evaluate if pulmonary artery (PA) reactivity to MH identifies fetuses that will develop pulmonary hypertension.

    4. Predict neonatal survival and pulmonary hypertension by measurement of PA reactivity to MH in fetuses at risk of neonatal respiratory morbidity.

    5. Assess serial changes in maternal haemodynamics (cardiac output (CO), stroke volume (SV) and systemic vascular resistance (SVR)) before, during and after MH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The inclusion criteria can be divided into 3 main categories:

    A) Those at risk of respiratory morbidity at term

    • Iatrogenic elective Caesarean section being performed < 38 gestational weeks in an otherwise well baby. This subgroup will be informative in relation to circulatory adaptation close to term.

    B) Those at risk of pulmonary hypoplasia

    • Patients with mid trimester PPROM
    • Patients with persistent oligohydramnios of renal or nonrenal origin
    • Patients whose fetuses have known: Congenital diaphragmatic hernia (CDH), Congenital cystic adenomatoid malformation (CCAM)
    • Other space occupying lesions of the thorax (cardiomegaly, pleural effusion and skeletal dysplasia).

    C) Those at risk of respiratory morbidity due to a cardiac cause

    • Women whose fetuses have a prenatal diagnosis of moderate/severe perimembranous ventricular septal defect (VSD)/atrioventricular septal defect (AVSD) in the absence of other structural heart disease including cases of Trisomy 21. The MH test may contribute to prediction of the need for neonatal intervention in this group.

    E.4Principal exclusion criteria
    The exclusion criteria are as follows:

    • Maternal age < 18 years
    • Known fetal chromosomal abnormality excluding Trisomy 21
    • Gestational age <31 weeks and >40 weeks
    • Maternal chronic respiratory disease (including COPD, Cystic Fibrosis, Pulmonary Fibrosis)
    • Maternal congenital heart disease
    • Maternal use of bleomycin or amiodarone

    The justification for the exclusion criteria are as follows:

    • An adult is defined as a person aged 18 years or over.
    • The literature indicates that maternal hyperoxygenation does not alter fetal pulmonary circulation until after 31 weeks and therefore we will perform the test after 31 weeks gestation.
    • The use of high flow oxygen is contraindicated in patients with chronic respiratory disease.
    • Pregnant women with congenital heart disease are high risk antenatal patients and will be excluded to avoid them being exposed to high flow oxygen and to avoid any misinterpretation of the NICOM.
    • High flow oxygen should be avoided in any person taking the medications bleomycin or amiodarone.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the occurrence pulmonary hypertension in the neonate measured using echocardiography on Day 1 and 2 of age.

    The presence of pulmonary hypertension in the neonate will be formally assessed with a neonatal echocardiogram performed at two separate time points, at 6-12hours of life and at 36-48 hours of life. Persistent pulmonary hypertension will be defined as a pulmonary pressure greater than two thirds the systemic pressure beyond the initial 12 hours of life.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary end point(s)
    Secondary endpoints:
    Severity of pulmonary hypertension
    Composite of neonatal respiratory morbidity (Respiratory Distress Syndrome and Transient Tachypnea of the Newborn)
    Neonatal intensive care unit (NICU) admission
    28 day survival
    Survival to discharge from hospital
    Umbilical Artery and vein pHs and base excess
    Neonatal interventions required:
    • Chest compressions
    • Intubation
    • Peak inspiratory pressure (PIP)
    • Mean arterial pressure (MAP)
    • Positive end expiratory pressure (PEEP)
    • Adrenaline bolus at birth
    • Hydrocortisone pre transfer
    • Inotrope infusion pre transfer
    • Nitric
    • Surfactant
    • High frequency oscillatory ventilation (HFOV) at birth
    • Intravenous antibiotics
    • Nitric oxide duration
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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
    Pilot Study. Prospective cohort Study.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 60
    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 No
    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 state60
    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 Decision2016-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-22
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