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    Summary
    EudraCT Number:2010-021576-28
    Sponsor's Protocol Code Number:DFG Fr 1455/6-1
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2010-021576-28
    A.3Full title of the trial
    Effects of transfusion thresholds on neurocognitive outcome of extremely low birth weight infants (ETTNO) a blinded randomized controlled multicenter trial
    A.3.2Name or abbreviated title of the trial where available
    ETTNO
    A.4.1Sponsor's protocol code numberDFG Fr 1455/6-1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinikum Tuebingen
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.2.5The 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 Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typestandard blood product: erythrocyte concentrate
    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
    extreme prematurity
    anemia of prematurity
    neurodevelopmental impairment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10002307
    E.1.2Term Anemia of prematurity
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10036615
    E.1.2Term Prematurity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether ‘liberal’ red blood cell transfusion (RBCT) practices that intend to keep the hematocrit levels ≥ 28% at all time during the initial hospitalization improve or impair long-term outcome (i.e., reduce or increase the incidence of death or major neurodevelopmental impairment evaluated at 24 months corrected age) in extremely low birth weight infants if compared with ‘restrictive’ RBCT guidelines that accept hematocrit levels as low as 21% (according to pre-specified RBCT guidelines).
    E.2.2Secondary objectives of the trial
    To determine whether RBCT-guidelines have an effect on short-term outcomes such as in-hospital growth and mortality, and the incidences of the major diseases of prematurity (i.e., BPD, ROP, necrotizing enterocolitis (NEC), intestinal perforation, brain injury on cranial ultrasound, and patent ductus arteriosus (PDA) requiring therapy), or long-term outcomes such as growth and mortality until follow-up, the mental and physical developmental index scores, and the incidences of the individual components of the primary composite outcome.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancillary study A (“Effects of intermittent hypoxemic episodes and anemia on neurocognitive outcome”) aims to answer the following research question:
    sub-a1) Do RBCT guidelines and resulting hemoglobin concentrations have an impact on the effect of intermittent hypoxemic episodes on neurocognitive outcome or retinopathy of prematurity?
    sub-a2) Are low oxygen content rather than low oxygen saturation values indicative for poor neurocognitive outcome or retinopathy of prematurity.

    Ancillary study B (“Better indicators than hematocrit to predict a short-term clinical benefit from RBCT”) aims to answer the following research question:
    sub-b1) Do concentrations of VEGF in plasma and urine predict the “need of RBCT” (defined as a pre-defined response of clinical signs of anemia to the RBCT) with a higher precision than the hematocrit (the concentration of hemoglobin)?
    sub-b2) Does the cerebral oxygen saturation measured by near infrared spectroscopy predict the “need of RBCT” (defined as a pre-defined response of clinical signs of anemia to the RBCT) with a higher precision than the hematocrit (the concentration of hemoglobin)?

    Ancillary study C (“Effects of transfusion thresholds on urinary peroxidation products”) aims to answer the following research question:
    sub-c) Do RBCT-guidelines influence markers of oxidative stress and are such markers related to complications of prematurity (ROP, BPD, ventricular dilatation, etc. ) or neurocognitive outcome?

    Ancillary study D (“Evaluation of the incidence of transfusion complications and particularly transfusion related lung injury (TRALI) in preterm infants”) aims to answer the following research question:
    sub-d) What is the incidence of transfusion complications and TRALI in ELBW infants?
    E.3Principal inclusion criteria
    birth weight 400-999g
    E.4Principal exclusion criteria
    Missing written parental consent.
    Gestational age > 29 + 6/7 weeks
    Major congenital anomalies
    Clinical decision to withhold intensive care
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure of this study will be the long-term neurocognitive development measured as the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity (where major neurodevelopmental impairment is defined as any of the following: cognitive delay defined as mental developmental index (MDI) score of the Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment)
    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 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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer blind
    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.8.2.3.1Comparator description
    different hematocrit trigger thresholds for indication
    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 concerned29
    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 Information not present in EudraCT
    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 trial ends for the individual patient at the follow-up visit at 24 months corrected age. The trial finally ends at the at the follow-up visit at 24 months corrected age of the last patient enrolled.
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    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
    very preterm infants with birth weights 400 - 1000g
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state920
    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)
    After their participation in the trial, all patients will be treated with standard treatment (if any treatment is required at all) and standard follow-up with the family paediatrician plus additional specialized neurodevelopmental / pulmonary / cardiac / ... follow-up if required.
    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 Decision2011-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-18
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