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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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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    Summary
    EudraCT Number:2016-003670-40
    Sponsor's Protocol Code Number:PAN.1
    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:2017-12-06
    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 number2016-003670-40
    A.3Full title of the trial
    Pediatric Ards Neuromuscular blockade (PAN) study: Life-threatening acute respiratory failure in children: to breathe or not to breathe spontaneously, that's the question.
    Pediatrisch Ards Neuromusculaire blokkade (PAN) studie: Levensbedreigend acuut respiratoir falen bij kinderen: wel of niet spontaan ademen, dat is de vraag.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of medication that induces paralysis in children with life-threatening acute respiratory failure.
    Het effect van spierverslappers bij kinderen met levensbedreigend acuut respiratoir falen.
    A.3.2Name or abbreviated title of the trial where available
    PAN study
    PAN studie
    A.4.1Sponsor's protocol code numberPAN.1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02902055
    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 SponsorBeatrix Children's Hospital, University Medical Center Groningen
    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.4.1Name of organisation providing supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeatrix Children's Hospital, University Medical Center Groningen, Department of Paediatrics
    B.5.2Functional name of contact pointMartin C. J. Kneyber
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 30.001
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31050 3614242
    B.5.6E-mailm.c.j.kneyber@umcg.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 Esmeron
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon
    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 injection
    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.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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sodium Chloride 0,9%
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    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 injection
    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.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
    Pediatric Acute Respiratory Distress Syndrome necessitating mechanical ventilation
    Pediatrisch Acuut Respiratoir Distress syndroom, waarvoor mechanische beademing noodzakelijk is.
    E.1.1.1Medical condition in easily understood language
    Severe lung injury that requires mechanical ventilation
    Een ernstige longaandoening, waarvoor mechanische beademing noodzakelijk is
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to test the hypothesis that early use of neuromuscular blocking agents for 48 hours in paediatric patients younger than 5 years of age with moderate – to – severe paediatric acute respiratory distress syndrome will lead to a reduction in respiratory morbidity 12 months after discharge from the paediatric intensive care unit (PICU).

    Het primaire doel is om de hypothese te toetsen dat vroegtijdig gebruik van neuromusculaire blokkers gedurende 48 uur bij kinderen onder de 5 jaar met matig tot ernstig pediatrisch acuut respiratoir distress syndroom leidt tot een reductie in respiratoire morbiditeit 12 maand na ontslag van de pediatrische intensive care unit (PICU).
    E.2.2Secondary objectives of the trial
    1. Effects of neuromuscular blocking agents on pulmonary and systemic inflammation
    2. Effects of neuromuscular blocking agents on oxygenation and ventilation
    3. Effects of neuromuscular blocking agents on respiratory system mechanics
    4. Incidence of adverse drug reactions related to rocuronium
    a. Occurrence of hypotension or tachycardia with the need for intervention by means of medication or fluid challenge
    b. Number of re-intubations
    5. Concomitant use of sedatives and/or analgesics
    6. Prevalence of critical illness polyneuropathy and myopathy
    7. Prevalence of ventilator – associated pneumonia
    8. Number of hours on mechanical ventilation
    9. Number of ventilator-free days
    10. Length of PICU stay
    11. Association between midazolam exposure (including metabolites) and inflammation and its contribution to clinical endpoints
    1. Effect van neuromusculaire blokkers op de pulmonale en systemische inflammatie
    2. Effect van neuromusculaire blokkers op oxygenatie en ventilatie
    3. Effect van neuromusculaire blokkers op mechanica van het respiratoire systeem
    4. Incidentie van bijwerkingen op rocuronium
    a. Voorkomen van hypotensie of tachycardie, waarvoor interventie middels medicatie of fluid challenge nodig is
    b. Aantal herintubatie
    5. Gebruik van sedativa en/of analgetica
    6. Prevalentie van critical illness polyneuropathie en myopathie
    7. Prevalentie van ventilator-geassocieerde pneumonie
    8. Aantal uren aan mechanische beademing
    9. Aantal ventilatorvrije dagen op dag 28
    10. Duur van PICU-opname
    11. Associatie tussen midazolam exposure (inclusief metabolieten) en inflammatie en de bijdrage aan klinische eindpunten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent
    - Age younger than 5 years
    - Need for invasive mechanical ventilation with PEEP 5 cmH2O
    - Early moderate – to – severe paediatric acute respiratory distress syndrome originating from any cause: - Acute onset of disease, and - Oxygenation index > 12, and - One or more (bilateral) infiltrates on chest radiograph, and - No evidence of left ventricular failure or fluid overload, and - Within the first 96 hours of PICU admission
    - Sedation defined by Comfort – B scale between 11 - 17
    - Informed consent
    - Leeftijd onder de 5 jaar
    - Invasieve mechanische beademing met PEEP 5 cm H2O noodzakelijk
    - Vroeg matig tot ernstig pediatrisch acuut respiratoir distress syndroom, ongeachte welke oorzaak: - plotseling beging van ziekte, - oxygenatie index > 12, - één of meer (bilaterale) infiltraten op thoraxradiografie, - geen aanwijzingen voor linker ventrikel falen of overvulling, - binnen de eerste 96 uur van opname op de PICU
    - Sedatie gedefineerd door Comfort-B scale tussen 11 - 17
    E.4Principal exclusion criteria
    - No informed consent
    - Known allergy or intolerance to rocuronium
    - Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for paediatric acute respiratory distress syndrome
    - Bolus administration of neuromuscular blockade within 1 hour before meeting PARDS criteria
    - Chronic respiratory failure on home ventilation
    - Intracranial hypertension
    - Bone marrow transplantation
    - Pre-existing pulmonary hypertension
    - Congenital heart disease with left - to - right shunting
    - Cyanotic congenital heart disease
    - Expected duration of mechanical ventilation less than 48 hours
    - Withdrawal of life–sustaining treatment
    - Geen informed consent
    - Bekende allergie of intolerantie voor rocuronium
    - Continue toediening van neuromusculaire blokker voorafgaand aan het tijdstip dat voldaan wordt aan de criteria voor pediatrisch acuut respiratoir distress syndroom
    - Toediening van een bolus van neuromusculaire blokker voorafgaand aan het tijdstip dat voldaan wordt aan de criteria voor pediatrisch acuut respiratoir distress syndroom.
    - Chronisch respiratoir falen aan thuisbeadming
    - Intracraniële hypertensie
    - Beenmergtransplantatie
    - Pre-existente pulmonale hypertensie
    - Congenitale hartafwijking met link-rechts shunting
    - Cyanotische congenitale hartafwijking
    - Verwachte duur van mechanische beademing minder dan 48 uur
    - Staken van levenverlengende behandeling
    E.5 End points
    E.5.1Primary end point(s)
    At least a 20% reduction in the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking.

    Een reductie in de cumulative respiratory morbidity score van ten minste 20% 12 maanden na ontslag van de PICU, gecorrigeerd voor leeftijd, zwangerschapsduur, familie historie van astma en/of allergie, seizoen waarin de vragenlijst is ingevuld en roken door ouders.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after PICU discharge.
    12 maanden na ontslag van de PICU
    E.5.2Secondary end point(s)
    1. Lung clearance index (LCI)
    2. Functional residual capacity (FRC)
    3. Level and time course of the cumulative respiratory morbidity score assessed at 3, 6 and 9 months after PICU discharge
    4. Level and time course of ventilator settings: peak inspiratory pressure, plateau pressure, mean airway pressure, driving pressure, positive end–expiratory pressure, set rate, total rate, inspiratory time
    5. Level and time course of respiratory system mechanics: quasi–static compliance, dynamic compliance, resistance
    6. Level and time course of oxygenation: SpO2/FiO2 ratio, PaO2/FiO2 ratio, oxygenation index, oxygen saturation index
    7. Level and time course of ventilation: PCO2, pH
    8. Level and time course of haemodynamic profile: heart rate, blood pressure, central venous pressure, daily cumulative fluid balance, number of fluid challenges
    9. Level and time course of the non-respiratory PELOD–2 score
    10. Number of adverse drug reactions
    11. Number of re-intubations
    12. Daily cumulative dosage sedatives
    13. Daily cumulative dosage analgesics
    14. Daily type and quantity of nutrition
    15. Level and time course of pulmonary inflammatory response
    16. Level and time course of systemic inflammatory response
    17. Prevalence of critical illness polyneuropathy and myopathy
    18. Prevalence of ventilator–associated pneumonia
    19. The number of hours on mechanical ventilation
    20. The number of ventilator-free days at day 28
    21. The length of PICU stay
    22. Association between midazolam exposure (including metabolites) and inflammation and its contribution to clinical endpoints
    1. Lung clearance index (LCI)
    2. Functionele residuaal capaciteit (FRC)
    3. Niveau en verloop in de tijd van de cumulative respiratory morbidity score
    4. Niveau en verloop in de tijd van de ventilatorinstellingen: peak inspiratory pressure, plateau pressure, mean airway pressure, driving pressure, positive end-expiratory pressure, ingestelde frequentie, totale frequentie, inspiratietijd
    5. Niveau en verloop in de tijd van de mechanica van het respiratoire systeem: quasi-static compliance, dynamic compliance, resistance
    6. Niveau en verloop in de tijd van de oxygenatie: SpO2/FiO2 ratio, PaO2/FiO2 ratio, oxygenation index, oxygen saturation index
    7. Niveau en verloop in de tijd van de ventilatie: PCO2, pH
    8. Niveau en verloop in de tijd van het hemodynamischeprofiel: hartfrequentie, bloeddruk, centraal veneuze druk, dagelijkse vochtbalans, aantal fluid challenges
    9. Niveau en verloop in de tijd van de non-respiratory PELOD-2 score
    10. Aantal bijwerkingen
    11. Aantal herintubaties
    12. Dagelijkse cumulatieve dosis sedativa
    13. Dagelijkse cumulatieve dosis analgetica
    14. Dagelijks type en hoeveelheid voeding
    15. Niveau en verloop in de tijd van de pulmonale inflammatoire respons
    16. Niveau en verloop in de tijd van de systemische inflammatoire respons
    17. Prevalentie van critical illness polyneuropathie en myopathie
    18. Prevalentie van ventilator-geassocieerde pneumonie
    19. Het aantal uren aan mechanische beademing
    20. Het aantal ventilatorvrije dagen op dag 28
    21. Duur van de PICU-opname
    22. Associatie tussen midazolam exposure (inclusief metabolieten) en inflammatie en de bijdrage aan klinische eindpunten
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2: 12 months after PICU discharge
    3. 3, 6, and 9 months after PICU discharge
    4, 5, 6, 7, 8: baseline and 12, 24, 36, 48, 72, 96 and 120 hours after randomisation
    9. baseline and 24, 72 and 120 hours after randomisation
    10, 11, 12, 13, 14: During PICU stay
    15, 16: baseline and after 24 and 72 hours after randomisation
    17, 18: from 48 hours after randomization untill discharge PICU
    19, 20, 21: -
    22. During PICU stay
    1 en 2: 12 maanden na ontslag van de PICU
    3. 3, 6 en 9 maanden na ontslag van de PICU
    4, 5, 6, 7, 8: baseline en 12, 24, 36, 48, 72, 96 en 120 uur na randomisatie
    9. baseline en 24, 72 en 120 uur na randomisatie
    10, 11, 12, 13, 14: Gedurende opname op de PICU
    15, 16: baseline en 24 en 72 uur na randomisatie
    17,18: vanaf 48 na randomisatie tot ontslag PICU
    19, 20, 21: -
    22. Gedurende opname op de PICU
    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 No
    E.6.4Safety No
    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) 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 Yes
    E.8.1.5Parallel group No
    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 concerned6
    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
    Laatste bezoek van de laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 Yes
    F.1.1Number of subjects for this age range: 178
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 59
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 59
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The subjects are patients < 5 years old with severe, life-threatening paediatric acute respiratory distress syndrome and require invasive mechanical ventilation, for which they are usually sedated.
    De proefpersonen zijn patiënten onder de 5 jaar met ernstig pediatrisch acuut respiratoir distress syndroom waarvoor zij mechanisch beademd moeten worden, waarvoor zij over het algemeen gesedeerd zijn.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state178
    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)
    - In case of withdrawal from the trial, the physician taking over care of the patient after PICU discharge is informed about the study participation and the withdrawal.
    - All adverse events will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist
    - In geval van terugtrekken uit de studie, zal de arts die de zorg van de patiënt overneemt na ontslag van de PICU geïnformeerd worden over de deelname aan de studie en het terugtrekken.
    - Alle adverse events worden vervolgd tot ze zijn verdwenen of tot er een stabiele situatie is bereikt. Afhankelijk van het event, zal voor de follow-up op indicatie soms extra onderzoek of medische behandeling nodig zijn of verwijzing naar de huisarts of een medisch specialist.
    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 Decision2017-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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