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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2022-003415-29
    Sponsor's Protocol Code Number:2.0
    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:2023-01-06
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-003415-29
    A.3Full title of the trial
    The effect of antenatal acetaminophen administration on breathing effort of premature infants at birth: a pilot study
    Het effect van antenatale acetaminophen administratie op de ademhaling van te vroeggeboren kinderen bij geboorte: een pilot studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of paracetamol on breathing of premature infants at birth
    Het effect van paracetamol op de ademhaling van te vroeggeboren kinderen bij geboorte
    A.3.2Name or abbreviated title of the trial where available
    AIR study
    AIR studie
    A.4.1Sponsor's protocol code number2.0
    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 SponsorLeiden University Medical Centre
    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 supportLeiden University Medical Centre
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointResearcher overseeing project
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    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. name Paracetamol Fresenius Kabi RVG 10 mg/ml oplossing voor infusie
    D. of the Marketing Authorisation holderFresenius Kabi Nederland B.V.
    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 Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Pregnant women expected to deliver between 24 and 30 weeks' gestation
    Zwangere vrouwen met een verwachte geboorte tussen 24 en 30 weken zwangerschapsduur.
    E.1.1.1Medical condition in easily understood language
    Pregnant women expected to give birth between 24 and 30 weeks of gestation (pregnancy duration).
    Zwangere vrouwen met een verwachte geboorte tussen 24 en 30 weken zwangerscahpsduur.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033762
    E.1.2Term Paracetamol
    E.1.2System Organ Class 100000004848
    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 objective of this study is to evaluate the feasibility of antenatal paracetamol administration to pregnant women 0.5-2 hours prior to birth.
    Het doel van het onderzoek is om primair te evalueren hoe haalbaar paracetamol toediening 0.5-2 uur voor geboorte is.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to compare the effect of antenatal acetaminophen administration to standard care on breathing effort, which is expressed as minute volume of spontaneous breathing in the first 1-5 minutes after birth, of premature infants at birth.
    Secundair vergelijken we het effect van antenatale paracetamol toediening ten opzichte van standaard zorg op de ademhaling, gedefinieerd als minuut volume van spontane ademhaling in de eerste 1-5 minuten na geboorte, in te vroeggeboren kinderen bij geboorte.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pregnant women expected to deliver between 24+0-29+6 weeks’ gestation and admitted to the LUMC.
    - Informed consent from caregiver(s) (see 10.2).
    - Zwangere met een verwachte vroeggeboorte tussen 24+0 en 29+6 weken zwangerschapsduur die opgenomen zijn in het LUMC.
    - Informed consent van de voogd(en).
    E.4Principal exclusion criteria
    - Fetuses with congenital anomalies affecting the heart, lungs, kidneys or liver.
    - Pregnant women in whom the use of acetaminophen is contraindicated for any reason, consisting of: severe renal impairment, severe hepatic impairment, severe active liver disease (including HELLP-syndrome), a known alcohol addiction and a known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
    - Pregnant women that use one of the following medication: probenecid, salicylamide, rifampicin, isoniazid, barbiturates, tricyclic antidepressants, anti-epileptic medication, zidovudine, oral coagulants, metoclopramide, domperidone, colestyramine and imatinib.
    - Acetaminophen administration required for standard care within 4 hours prior to birth.
    - Decision to give palliative care to the neonate.
    - Foetussen met aangeboren afwijkingen aan hart, longen, nieren of lever.
    - Zwangere vrouwen bij wie het gebruik van acetaminophen om welke reden dan ook gecontra-indiceerd is, bestaande uit: ernstige nierfunctiestoornis, ernstige leverfunctiestoornis, ernstige actieve leverziekte (inclusief HELLP-syndroom), een bekende alcoholverslaving en een bekende overgevoeligheid voor acetaminophen of voor één van de hulpstoffen in de intraveneuze formulering.
    - Zwangere vrouwen die een van de volgende geneesmiddelen gebruiken: probenecide, salicylamide, rifampicine, isoniazide, barbituraten, tricyclische antidepressiva, anti-epileptische geneesmiddelen, zidovudine, orale stollingsmiddelen, metoclopramide, domperidon, colestyramine en imatinib.
    - Acetaminophen administratie nodig voor standaard zorg binnen 4 uur voor geboorte.
    - Besluit om de neonaat palliatieve zorg te geven.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study outcome is the feasibility, expressed as the success rate, n (%), of pregnant women in the intervention group receiving acetaminophen 0.5-2 hours prior to birth.
    De primaire uitkomstmaat is de haalbaarheid van antenatale paracetamol administratie, wat wordt gedefinieerd als het slagingspercentage, n (%), van zwangere vrouwen in de interventie groep die 0.5-2 uur voor geboorte paracetamol toegediend hebben gekregen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is evaluated directly after birth.
    De primaire uitkomstmaat wordt direct na geboorte beoordeeld.
    E.5.2Secondary end point(s)
    The secondary study outcome is breathing effort, expressed as average minute volume (mL/kg/min, continuous) in the first 1-5 minutes after birth, calculated using measured tidal volume of spontaneous breaths on CPAP (mL/kg/breath, continuous) and respiratory rate independent of respiratory support (breaths/min, continuous), and assessed by a respiratory function monitor used for respiratory support at birth in the LUMC (Advanced Life Diagnostics, Weener, Germany). .
    De secundaire uitkomstmaat is het effect van paracetamol op de ademhaling, gedefinieerd als het gemiddelde minuut volume van spontane ademhaling (mL/kg/min) in de eerste 1-5 minuten na geboorte. Minuut volume wordt berekend door het product van teugvolumes (mL/kg) en ademhalingsfrequentie (ademhalingen/min) en beide worden gemeten door een respiratoire functie monitor die gebruikt wordt in de opvangkamer van het LUMC (Advanced Life Diagnostics, Weener, Duitsland).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the time interval 1-5 minutes after birth.
    Tijdens het tijdsinterval 1-5 minuten na geboorte.
    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 No
    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. 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 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. trial design description
    Gedeeltelijke blindering van behandelingstoewijze voor alleen neonatoloog en onderzoeker (T.P.)
    Partial blinding of treatment allocation only to neonatologist and researcher (T.P)
    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. description
    Standaard zorg
    Standard care
    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
    The trial is ended when all included infants are no longer admitted to the neonatology intensive care unit in the LUMC (re-admissions are not part of the inclusion period). In accordance to section 10, subsection 4, of the WMO, the sponsor will suspend the study if there is sufficient ground that continuation of the study will jeopardise subject health or safety (specified in protocol section 7.7).
    Het onderzoek wordt beëindigd wanneer alle geïncludeerd kinderen niet meer zijn opgenomen op de neonatale intensive care unit van het LUMC (heropname vormen geen deel van de inclusie periode). Overeenkomstig artikel 10, 4e lid van de WMO, stopt de sponsor het onderzoek vroegtijdig als er voldoende grond is dat voortzetting van het onderzoek de gezondheid of veiligheid van de proefpersonen in gevaar brengt (zie protocol sectie 7.7).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.1.1In Utero Yes
    F. of subjects for this age range: 40
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F. of subjects for this age range: 40
    F.1.1.3Newborns (0-27 days) Yes
    F. of subjects for this age range: 40
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F. of subjects for this age range: 40
    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 Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    (Premature) infants can not give informed consent for study participation at birth and consent is therefore the parents/ caregivers of the infants are asked for informed consent.
    (vroeggeboren) kinderen kunnen geen informed consent afgeven bij geboorte waardoor de ouders/ voogden van de kinderen worden gevraagd voor om informed consent af te geven.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    The attending physician is responsible to instruct care or treatment of the subjects after the participation in the trial has ended.
    De behandelend arts is verantwoordelijk voor de behandeling of zorg van proefpersonen nadat hun participatie in het onderzoek is beëindigd.
    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 Decision2022-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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