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    Summary
    EudraCT Number:2019-003666-41
    Sponsor's Protocol Code Number:MEC2020-0078
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-003666-41
    A.3Full title of the trial
    Doxapram versus placebo in preterm newborns:
    an international double blinded multicenter randomized controlled trial.
    Doxapram versus placebo in premature neonaten:
    een internationaal, multicenter, dubbel blind, gerandomiseerd, gecontroleerd onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Doxapram in preterm infants
    Doxapram in premature neonaten
    A.3.2Name or abbreviated title of the trial where available
    DOXA Trial
    DOXA Trial
    A.4.1Sponsor's protocol code numberMEC2020-0078
    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 SponsorErasmus MC University Medical Center
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University Medical Center
    B.5.2Functional name of contact pointHead Division of Neonatology
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031107036077
    B.5.6E-maili.reiss@erasmusmc.nl
    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 Dopram
    D.2.1.1.2Name of the Marketing Authorisation holderEUMEDICA NV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Gastroenteral use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXAPRAM HYDROCHLORIDE
    D.3.9.1CAS number 7081-53-0
    D.3.9.4EV Substance CodeSUB01823MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Compromised lung function results in impaired gas exchange and an increased work of breathing. Impaired control of breathing leads to apnea of prematurity (AOP; a cessation of breathing) which can lead to hypoxemia and bradycardia.
    Prematuren hebben een hoog risico op respiratoir falen door onderontwikkeling van het respiratoire systeem. Respiratoir falen is veroorzaakt door een aangetaste longfunctie en een verminderde controle over de ademhaling. Een verminderde longfunctie resulteert in een mindere gasuitwisseling en een verhoogde ademarbeid. Een verminderde controle over de ademhaling leidt tot 'apneus door prematuriteit' wat weer kan leiden tot hypoxemie en bradycardie.
    E.1.1.1Medical condition in easily understood language
    In children with early birth the brain and the lungs are not fully developed and, therefore, they 'forget' to breath, resulting in breathing pauzes. Oxygen shortage in the blood is the result.
    In te vroeg geboren kinderen zijn de hersenen en de longen niet helemaal volgroeid waardoor ze 'vergeten' adem te halen, met adempauzes als gevolg. Een zuurstoftekort is het bloed is het gevolg.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077323
    E.1.2Term Infantile mixed apnea
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of our trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairment/severe disability at 2 years corrected age as compared to placebo.
    Het hoofddoel van de studie is onderzoeken of doxapram veilig en effectief is in het verminderen van de samengestelde uitkomst overlijden en een verslechterde neurologische ontwikkeling/ernstig disfunctioneren op een gecorrigeerde leeftijd van 2 jaar vergeleken met een placebo.
    E.2.2Secondary objectives of the trial
    To study the direct effects of doxapram on the respiratory condition of the newborn, on the duration of NICU admission, and on short term morbidity as evaluated at the postmenstrual age of 36 weeks and at hospital discharge. Short term morbidity includes BPD, ROP, NEC, late onset sepsis, growth (body weight) and signs of abnormal brain development (on ultrasound and/or MRI).

    To validate the doxapram dosing using an available population PK/PD model

    To study short term adverse-effects and potential adverse drug reactions

    To study the long-term effects of doxapram on the health, neurodevelopment (including intelligence and school functioning) and quality of life of the children and their families at the age of 5.5 and 8 years (including patient and parent reported outcome).
    De directe effecten van doxapram bestuderen op de respiratoire conditie van een neonaat, op de duur van de NICU opname en overlijden op korte termijn (bepaald op een postmenstruele leeftijd van 36 weken en bij ziekenhuisontslag). Morbiditeiten op korte termijn zijn BPD, ROP, NEC, sepsis, afwijkende groei (lichaamsgewicht) en tekenen van abnormale ontwikkeling van de hersenen (op echo en/of MRI).

    De doxapram dosering evalueren met een bestaand populatie PK/PD model.

    Het bestuderen van de bijwerkingen op korte termijn.

    Het bestuderen van de doxapram effecten op lange termijn op de gezondheid, hersenontwikkeling (inclusief intelligentie en functioneren op school) en kwaliteit van leven van de kinderen en hun families op de leeftijd van 5.5 en 8 jaar (inclusief uitkomst gerapporteerd door patiënt en ouder).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study on additional neuromonitoring of study patients will be part of the study at some sites.
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Admitted to the NICU of one of the participating centres
    - Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium) parents or legal representatives
    - Gestational age at birth < 29 weeks
    - Caffeine therapy, adequately dosed
    - Optimal non-invasively supported according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, BIPAP/Duopap)
    - Apnea that require a medical intervention (indication to start doxapram if not in trial) as judged by the attending physician (*)

    (*)
    There is considerable variability between centers and physicians when the frequency and duration of apnea are considered unacceptable and an intervention (doxapram or intubation) is needed. For this reason, we have chosen a pragmatic study design with less strict inclusion criteria.
    Om geschikt te zijn voor inclusie in de studie moet ene patiënt aan de volgende criteria voldoen:
    - Opgenomen op de NICU op een van de deelnemende centra
    - Schriftelijke toestemming volgens de nationale richtlijnen van beide (Nederland) of minstens een (België) ouders of verzorgers
    - Zwangerschapduur bij geboorte <29 weken
    - Adequate therapie met coffeïne
    - Optimale non-invasieve support volgens het lokale behandelprotocol (met nasale CPAP of ventilatie ((S)NIPPV, BIPAP/Duopap)
    - Apneus waarvoor een medische interventie (indicatie om doxapram te starten wanneer niet in het onderzoek) nodig is volgens de behandelend arts (*)

    (*)
    De variabiliteit is aanzienlijk tussen verschillende centra en artsen om de frequentie en duur van een apneu te beoordelen als onacceptabel waarvoor een interventie (doxapram of intubatie) nodig is. Om deze reden hebben we voor een pragmatische studie opzet gekozen waarbij de inclusie criteria minder strikt zijn.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - previous use of open label doxapram
    - use of theophylline (to replace doxapram)
    - chromosomal defects (e.g. trisomy 13, 18, or 21)
    - major congenital malformations that:
    • compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia)
    • result in chronic ventilation (e.g. Pierre Robin sequence)
    • increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities,
    - palliative care or treatment limitations because of high risk of impaired outcome

    *Considerations
    Several conditions, such as sepsis, pneumonia, necrotizing enterocolitis (NEC) and patent ductus arteriosus (PDA) may present with apnea and respiratory failure. Distinction from apnea caused by prematurity is difficult or even impossible. Therefore, the suspicions of one of these diagnoses is not considered an exclusion criterion. However, systemic disease may result in a decision to primarily intubate the infant and not to include the patient in the trial at that time point. This decision is left to the attending physician and medical team.
    Een potentiële deelnemer die aan een van onderstaande criteria voldoet, zal geëxcludeerd worden van deelname aan de studie:
    - Eerder gebruik van open-label doxapram
    - Gebruik van theophylline (om doxapram te vervangen)
    - Chomosomale defecten (bijv. trisomie 13, 18 of 21)
    - Grote congenitale afwijkingen die:
    • longfunctie aantasten (e.g. surfactant eiwit deficiënties, congenitale hernia diaphragmatica)
    • resulteren in een chronisch ventilatie probleem (bijv. Pierre Robin sequentie)
    • het risico op overlijden of een ernstig verstoorde neurologische ontwikkeling verhogen (congenitale cerebrale malformaties, chromosomale
    abnormaliteiten
    - palliatieve zorg of behandelgrenzen door een verhoogd risico op een verslechterde uitkomst

    * Overwegingen:
    Verschillende aandoeningen, zoals sepsis, pneumonie, necrotiserende enterocolitis (NEC) en patent ductus ateriosus (PDA) kunnen gepaard gaan met apneus en respiratoir falen. Het onderscheidt maken van apneus die veroorzaakt zijn door prematuriteit is moeilijk of zelfs onmogelijk. Daarom is verdenking op een van deze aandoeningen geen exclusie criterium. Een systemische ziekte kan weer wel resulteren in een besluit om de patiënt primair te intuberen en om de patiënt niet in het onderzoek te includeren op dat moment. Deze beslissing is wordt overgelaten aan de behandelend arts en het medische team.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome will be death or severe disability at the age of 2 years corrected age.
    (or survival without severe disability)

    Disability will be defined as 1 or more of the following:
    - cognitive delay (Mental Development Index score <85 (1 SD below the mean of 100) on the Bayley Scales of Infant and Toddler Development, BSID III scores)
    - cerebral palsy (diagnosed if the child had a non-progressive impairment characterized by abnormal muscle tone and decreased range or control of movements, determined with the Gross Motor Function Classification System)
    - severe hearing loss (using audiometry)
    - bilateral blindness (defined as a corrected visual acuity < 20/200)
    Primaire uitkomst is overlijden of ernstige beperking op de gecorrigeerde leeftijd van 2 jaar.
    (of overleving zonder ernstige beperking)

    Beperking zal gedefinieerd worden als 1 of meer van onderstaande punten:
    - Cognitieve vertraging (Mental Development Index score <85 (1 SD onder het gemiddelde van 100) op de Bayley Scales of Infant and Toddler Development, BSID III scores)
    - Cerebrale parese (gediagnostiseerd als het kind een non-progressieve verstoring had gekarakteriseerd door een abnormale spierspanning en een verminderde controle of bereik van bewegingen, bepaald met de Gross Moto Function Classification System)
    - Ernstig gehoorsverlies (met behulp van audiometrie)
    - Bilaterale blindheid (gedefinieerd als een corrected visual acuity < 20/200)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 2 years of corrected age.
    Op de gecorrigeerde leeftijd van 2 jaar.
    E.5.2Secondary end point(s)
    Short term outcome variables include (international definitions will be used as described in the National registration guidelines):
    - BPD at 36 weeks post menstrual age according to NICHD criteria.
    - Death at the age of 36 weeks post menstrual age and at hospital discharge (hospital mortality)
    - combined outcome death or BPD at 36 wk PMA
    - Short term neonatal co-morbidity :
    o Incidence of endotracheal intubations after start study medication
    o number of days on invasive ventilation,
    o number of days on ventilatory support (non-invasive ventilation, CPAP, humidified high flow),
    o number of days with supplemental oxygen
    o length of stay on the intensive care
    o cumulative number of apnea , number of incidents associated with bradycardia (optional)
    o incidence of late onset sepsis (culture proven or clinical suspected) after inclusion,
    o solitary intestinal perforation
    o necrotizing enterocolitis > stage 2 according to Bell,
    o IVH
    o PVL
    o Growth, length, HC at 36 weeks PMA
    o retinopathy of prematurity

    - Additional long term outcome at 2 years corrected age
    o readmissions since first discharge home
    o weight, length and head circumference at 24 months c.a.
    o behavioral problems (Child Behavior Checklist)

    - Parent reported outcome with the PARCA-R questionnaire
    - Long term follow-up until the age of 5.5 and 8 years to determine long term effects on neurodevelopment (including subscores of primary outcome such as Bayley III Scales ), health, quality of life.

    - Adverse-effects and potential adverse drug reactions will be monitored and analyzed.
    Uitkomsten op korte termijn zijn (internationale definities zoals beschreven in de National registration guidelines zullen gebruikt worden):
    - BPD op een postmenstruele leeftijd van 36 weken volgens de NICHD criteria
    - Overlijden op een postmenstruele leeftijd van 36 weken en bij ziekenhuisontslag (ziekenhuis overlijden)
    - Gecombineerde uitkomst van overlijden of BPD op een postmenstruele leeftijd van 36 weken
    - Neonatale comorbiditeiten op korte termijn:
    o Incidentie van endotracheale intubaties na de start van de studie medicatie,
    o Aantal dagen aan de invasieve ventilatie,
    o Aantal dagen beademingsondersteuning (non-invasieve ventilatie, CPAP, humidified high flow),
    o Aantal dagen met extra toegediende zuurstof,
    o Opnameduur op de intensive care
    o Cumulatief aantal apneus, aantal incidenten geassocieerd met bradycardie (optioneel)
    o Incidentie van late-onset sepsis (positieve kweek of klinische verdenking) na inclusie,
    o Solitaire darmperforatie
    o necrotizerende enterocolitis > stage 2 volgens Bell,
    o IVH
    o PVL
    o Groei, lengte, hoofdomtrek op de postmenstruele leeftijd van 36 weken
    o retinopatie van prematuriteit

    - Aanvullende uitkomsten op een gecorrigeerde leeftijd van 2 jaar:
    o Heropname sinds het eerste ontslag
    o Gewicht, lengte en hoofdomtrek op 24 maanden gecorrigeerde leeftijd
    o Gedragsproblemen (Child Behavior Checklist)

    - Ouder gerapporteerde uitkomsten met de PARCA-R vragenlijst
    - Het vervolgen op lange termijn op de leeftijd van 5.5 en 8 jaar om te lange termijn effecten op de neurologische ontwikkeling (inclusief sub-scores van de primaire uitkomst zoals de Bayley III Scales), gezondheid, kwaliteit van leven.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At postmenstrual age of 36 week, at hospital discharge, after 2, 5.5, and 8 years of corrected age.
    Op een postmenstruele leeftijd van 36 weken, bij ziekenhuisontslag, na 2, 5.5 en 8 jaar gecorrigeerde leeftijd.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Laatste bezoek van de laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    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: 396
    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: 396
    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
    Written informed consent has to be obtained from both (Netherlands) or at least one (Belgium) of the parents or care-givers from the preterm infants.
    Toestemming om mee te doen aan het onderzoek wordt schriftelijk gevraagd aan minimal één (Belgie) of beide ouders (Nederland) of verzorgers van de premature neonaten.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 396
    F.4.2.2In the whole clinical trial 396
    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)
    Subjects will be treated as normal after participation in the trial.
    De deelnemers aan het onderzoek zullen behandeld worden als normaal.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Neonatologie Netwerk Nederland (N3)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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