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    The EU Clinical Trials Register currently displays   36582   clinical trials with a EudraCT protocol, of which   6042   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:2011-005717-36
    Sponsor's Protocol Code Number:1645-CI-057
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-005717-36
    A.3Full title of the trial
    Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.
    Recién nacidos con edad gestacional extremadamente baja asignados al azar , a ciegas, para ser resucitados con un 21% frente al 60% de oxígeno: influencia sobre la mortalidad y las enfermedades crónicas en el período neonatal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Newborns smaller than normal who will be randomly and blindly assigned to 21% oxygen or 60% oxygen to be resuscitated to investigate the influence upon mortality and chronic conditions in the neonatal period
    Recién nacidos menos desarrollados que de normal, asignados al azar y de manera ciega a ser resucitados con un 21% de oxígeno ó un 60% de oxígeno, con el fin de investigar la influencia sobre la mortalidad y las enfermedades crónicas en el período neonatal.
    A.4.1Sponsor's protocol code number1645-CI-057
    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 SponsorInstituto de Investigación Sanitaria La Fe
    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 supportCAIBER
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigacion Sanitaria La Fe
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAv. Campanar 21
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46009
    B.5.4Telephone number34961973313
    B.5.5Fax number3496349 4416
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOXIGENO MEDICINAL LÍQUIDO OXIGEN SALUD, 99,5% gas para inhalación
    D.3.2Product code OX
    D.3.4Pharmaceutical form Inhalation gas
    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 7782-44-7
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 60
    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
    Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birth
    Recién nacidos prematuros de 30 semanas o menos, que necesitan reanimación / estabilización con maniobras de ventilación con presión positiva inmediatamente después de nacer
    E.1.1.1Medical condition in easily understood language
    Preterm infants aged 30 weeks or less, who need ventilation for resuscitation immediately after birth.
    Recién nacidos prematuros de 30 semanas o menos, que necesitan reanimación con ventilación inmediatamente después de nacer.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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
    To investigate whether intervention consisting in lowering the initial inspiratory fraction of oxygen to 21% as compared to 60% in depressed extremely low gestational age neonates enhances
    survival without bronchopulmonary dysplasia (need for oxygen supplementation at 36 weeks corrected age).
    Investigar si la intervención consiste en la reducción de la fracción inspiratoria de oxígeno inicial al 21% en comparación con el 60% de los recién nacidos deprimidos de edad gestacional extremadamente baja, potencia la supervivencia sin displasia broncopulmonar (necesidad de oxígeno suplementario a las 36 semanas de edad corregida).
    E.2.2Secondary objectives of the trial
    * Survival with reduced incidence of oxidative stress derived conditions:
    (i) retinopathy of prematurity (ROP)
    (ii) persistent ductus arteriosus (PDA)
    (iii) intra-periventricular hemorrhage and/or leukomalacia (IPVH/LM)
    (iv) necrotizing enterocolitis (NEC)

    * Improving neurological outcome measured using the complete Bayley III scale (motor and psychological development) at 24 months postnatal.

    * Reducing oxidative stress, oxidative damage to cell components and inflammation, DNA repair mechanisms as measured by specific biomarkers in the early postnatal period (<7 days postnatal).
    * La supervivencia con una menor incidencia de las condiciones de estrés oxidativo derivado:
    (i) la retinopatía del prematuro (ROP)
    (ii) la persistencia de conducto arterioso (PDA)
    (iii) intra-periventricular hemorragia y / o periventricular (IPVH / LM)
    (iv) la enterocolitis necrotizante (NEC)

    * Mejoría en las variables neurológicas medidas utilizando la escala de Bayley III completa (motor y el desarrollo psicológico) a los 24 meses después del parto.

    * Reducción del estrés oxidativo, daño oxidativo a los componentes de la célula y la inflamación, los mecanismos de reparación del ADN medidos por marcadores biológicos específicos en el período postnatal temprano (<7 días después del parto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preterm infants with gestational age of 30 weeks or less gestation born in tertiary referral centers and needing resuscitation/stabilization maneuvers with positive pressure ventilation immediately after birth
    Recién nacidos prematuros con edad gestacional de 30 semanas de gestación, o menos, nacidos en centros de tercer nivel y que necesitan reanimación / estabilización de las maniobras de ventilación con presión positiva inmediatamente después del nacimiento
    E.4Principal exclusion criteria
    Uncertainty about gestational age
    Refusal to participate (parents/guardian)
    Not fulfilling study protocol
    Decoding in the delivery room
    Major malformations
    Incertidumbre acerca de la edad gestacional ?
    La negativa a participar (padres / tutores)
    El incumplimiento de protocolo de estudio
    Decodificación en la sala de partos
    Malformaciones graves.
    E.5 End points
    E.5.1Primary end point(s)
    Survival without bronchopulmonary dysplasia (need for oxygen supplementation at 36 weeks post-conceptional age) in preterm infants aged ? 30 weeks gestation.
    Supervivencia sin displasia broncopulmonar en neonatos de 30 semanas de gestación o menos
    E.5.1.1Timepoint(s) of evaluation of this end point
    After birth and at 36 weeks post conceptional age.
    Al nacer y tras 36 semanas de la edad gestacional.
    E.5.2Secondary end point(s)
    * Survival with reduced incidence of oxidative stress derived conditions:
    (i) retinopathy of prematurity (ROP) grades 2 and 3 as defined by ETROP
    a. If in zone I: Stage 3 ROP, even without plus disease
    b. Plus disease with any stage ROP
    c. If in zone II: Plus disease with stage 2 ROP
    d. Plus disease with stage 3 ROP
    e. Any need for retinal surgery or the administration of avastin significant flow).
    (ii) intra-periventricular hemorrhage and/or leukomalacia (IPVH/LM) as detected by cranial ultrasonography (Papile LA et al J Pediatr 1983)
    (iii) necrotizing enterocolitis (NEC) (Bell?s classification Bell MJ Pediatr Clin N Amer 1985.

    * Time of oxygen supplementation needed (days)
    * Time of mechanical ventilation needed including CPAP (days)
    * Doses of surfactant needed (n)
    * Incidence of air leaks (%)
    * Improved neurological outcome determined by Bayley III scale (motor and psychological development) at 24 months postnatal.
    * Reducing oxidative stress, oxidative damage to cell components and inflammation as measured by specific biomarkers in the early postnatal period (<7 days postnatal):
    (i) Reduced (GSH) and oxidized (GSSG) glutathione ratio (Mass Spectrometry)
    (ii) Interleukin 8 (ELISA)
    (iii) TNF? (ELISA)
    (iv) Ortho-tyrosine / Phenylalanine ratio (HPLC coupled to MS/MS)
    (v) 8-hydroxy-2-deoxyguanosine / 2 deoxyguanosine ratio (HPLC coupled to MS/MS)
    (vi) Isoprostanes and Isofurans (Gas chromatography coupled to MS/MS)
    (vii) Targeted and Untargetted metabolomics
    (viii) DNA repair mechanisms
    (ix) Proteomics
    * Supervivencia con incidencia reducida del estres oxidativo en las siguientes condiciones:
    (i) retinopatia del prematuro grados 2 y 3, definido por ETROP
    a. Si zona I: Estadio 3 ROP, incluso sin enfermedad extra
    b. Enfermedad adicional en cualquier estadio ROP
    c. Si zona II: Enfermedad adicional con estadio 2 ROP
    d. Enfermedad adicional con estadio 3 ROP
    e. Cualquier necesidad de cirugía retinal o de administracion de avastin
    (ii) hemorragia intraperiventricular y/o leucomalacia (IPVH/LM) detectada por ultrasonografia cranial
    (iii) enterocolitis necrotizante (NEC)

    * Duracion necesidad de suplementacion con oxigeno (dias)
    * Duracion necesidad ventilacion mecanica incluyendo CPAP (Dias)
    * Dosis de surfactante necesario (n)
    * Incidencia perdidas aire (%)
    * Mejoria variable neurologica determinada por la escala Bayley III a los 24 meses del nacimiento
    * Reduccion del estres oxidativo, del daño oxidativo a los componentes celulares y de la inflamacion, medida a traves de biomarcadores especificos del periodo postnatal temprano (<7 dias):
    (i) Reduccion tasa GSH/GSSG (E.masas)
    (ii) Interleucina 8 (ELISA)
    (iii) TNF? (ELISA)
    (iv) Tasa ortotirosina/fenilalanina (HPLC acoplada a MS/MS)
    (v) Tasa 8-OH-2-deoxiguanosina/2-deoxiguanosina (HPLC acoplada a MS/MS)
    (vi) Isoprostanos e isofuranos (Cromatografia gases acoplada a MS/MS)
    (vii) Metabolitos diana y no diana
    (viii) Mecanismos reparacion ADN
    (ix) Proteonomica
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above (E.5.2)
    Ver arriba (E.5.2)
    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) 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 No
    E.8.2.3Other Yes
    E. description
    Mismo MI a diferente concentración/proporción
    Same IMP at a different concentration/proportion
    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 concerned2
    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
    The end of trial will coincide with the follow up visit at 24months of age.

    The End of Study Visit Form should include:Assessment of endpoints/outcome measures
    El final del ensayo coincidirá con la visita de seguimiento a 24 meses de edad.

    El formulario de visita de fin de estudio debería incluir: evaluación de las variables de estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 760
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F. of subjects for this age range: 760
    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. of subjects incapable of giving consent
    Paediatric population
    Poblacion pediatrica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state304
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 456
    F.4.2.2In the whole clinical trial 760
    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)
    Follow Up Clinic at 1, 6 and 12 months post-discharge; final evaluation at Follow Up Clinic including Bayley III scale of development (24 months)
    1, 6 y 12 meses después del alta, la evaluacion final incluye escla de desarrollo Bayley III a los 24 meses.
    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 Decision2012-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-12
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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