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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:2004-002170-34
    Sponsor's Protocol Code Number:2004-002170-34
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-20
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002170-34
    A.3Full title of the trial
    "Ensayo clínico controlado randomizado sobre el tratamiento precoz con insulina en recién nacidos de muy bajo peso"
    A.3.2Name or abbreviated title of the trial where available
    NIRTURE
    A.4.1Sponsor's protocol code number2004-002170-34
    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 SponsorCambridge University Hospital (Addenbrookes Hospital)
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    D.2.1.1.1Trade name NovoRapid
    D.2.1.1.2Name of the Marketing Authorisation holderNovo NOrdisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNovoRapid
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin aspart
    D.3.9.1CAS number 116094-23-6
    D.3.9.3Other descriptive nameNovo rapid
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typeInsulin aspart
    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
    Very low birth weight infants requiring intensive care have relative insulin deficiency often leading to hyperglycaemia during the first week of life. There is increasing evidence that the early postnatal period is critical for pancreatic development. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment.
    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 an early fixed dose insulin infusion, combined with variable dextrose support to maintain normoglycaemia, will reduce mortality at 28 days of age in the very low birth weight neonate.
    E.2.2Secondary objectives of the trial
    total number of days in neonatal intensive care prior to discharge home;
    (ii) episodes of sepsis in the first 2 weeks of life;
    (iii) growth at 28 days;
    (iv) severity of retinopathy of prematurity;
    (v) incidence of necrotizing enterocolitis
    (vi) incidence of intracranial haemorrhage
    (vii) chronic lung disease
    (viii) mortality before expected date of delivery
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    i) <1500g
    ii) <24 hours of age
    iii) Requiring intensive care and in whom it is considered appropriate to continue intensive care
    E.4Principal exclusion criteria
    i) Maternal diabetes including gestational diabetes
    ii) Babies where the appropriateness of continuing intensive care is being discussed
    iii) Major congenital anomalies
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy outcomes
    (i) Blood glucose control over the first week of life as assessed by the MiniMed subcutaneous continuous glucose monitor (CGMS)
    Primary outcome: Death within and including the first 28 days after delivery (where day 1 is considered as the first day of life)
    Secondary outcomes:
    i. Days of Neonatal Intensive Care: As defined by BAPM 200140 (appendix 1).
    ii. Episodes of sepsis in the first 2 weeks:
    a) Culture positive systemic infection will be defined as microbiologically positive cultures of blood, cerebrospinal fluid or suprapubic aspirate of urine plus clinical signs of sepsis.
    b) Culture negative infection will be defined as clinical signs suggestive of sepsis and considered to warrant >48 hours of antibiotics but with negative cultures.
    iii. Growth: All babies will have measurements of weight, length and head circumference at birth and every seven completed days after recruitment until 28 days of age. Growth will be assessed as change in weight, length and head circumference standard deviation score (SDS) from birth to 28 days of age.
    iv. Retinopathy of Prematurity: All these babies will be routinely screened (appendix 1), for retinopathy of prematurity and will be graded using the internationally recognised grading system 41,42 (appendix 1). Infants will be classified by the most severe degree of retinopathy.
    v. Incidence of necrotizing enterocolitis: defined as radiological evidence of necrotizing entercolitis assessed by consultant radiologist (appendix 1).
    vi. Incidence of intracranial haemorrhage: defined as cranial ultrasound evidence as assessed by Consultant Neonatologist (appendix 1).
    vii. Chronic Lung disease: defined as respiratory support or oxygen dependency at 36 weeks corrected gestational age 43 (appendix 1)
    viii. Death before expected date of delivery: taken as date considered to be most accurate estimate of delivery date
    Efficacy:
    i. Percent of time normoglycaemic: All babies will have a continuous glucose sensor in situ for the 7 completed days. Sensors will be inserted within 24 hours of birth and left in situ for 7 complete days from the time of insertion. This will take a measure of interstitial glucose every 5 minutes and will give an assessment of glucose control throughout the first week. The percent of time spent with blood glucose <2.6mmol/l, 2.6-10.0mmol/l, >10 mmol/l and <4.0, 4.0-8.0mmol/l, >8.0mmol/l will be measured.
    ii. IGF-I and IGFBP-1: measured in blood taken on days 1, 3, 8 and 28
    iii) cytokines: measured in blood taken on days 1, 3, 8 and 28
    iv) protein catabolism: measured by urinary 3-methylhistidine/creatinine ratio on day
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard treatment for VLBW infants
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Age of term (corrected gestational age) of last patient included.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Very Low Birthweight newborns
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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 Decision2006-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-15
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