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    Summary
    EudraCT Number:2010-023777-19
    Sponsor's Protocol Code Number:SToP-BPD
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-023777-19
    A.3Full title of the trial
    Systemic Hydrocortisone to Prevent Bronchopulmonary Dysplasia in Preterm INfants: the SToP-BPD Study.
    Systemische Hydrocrtoisone ter preventie van Bronchopulmonale Dysplasia bij Premature Pasgeborenen: de SToP-BPD studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hydrocortisone to prevent chronic lung disease in prematurely born newborn infants.
    Hydrocortisone ter preventie van chronisch longziekte bij te vroeggeborenen.
    A.3.2Name or abbreviated title of the trial where available
    SToP-BPD Study
    StoP-BPD Studie
    A.4.1Sponsor's protocol code numberSToP-BPD
    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 SponsorUZ Brussel
    B.1.3.4CountryBelgium
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center Amsterdam
    B.5.2Functional name of contact pointAnton van Kaam
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 22700
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100 DD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205663971
    B.5.6E-maila.h.vankaam@amc.uva.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 Solu-Cortef
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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.3.1Product namehydrocortisone
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNSolu-Cortef
    D.3.9.1CAS number 50-23-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number72.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchopulmonary dysplasia
    chronisch longziekte van de prematuur
    E.1.1.1Medical condition in easily understood language
    chronic lung disease of the prematurely newborn infant
    chronische longziekte van de tevroeggeborene
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the efficacy of hydrocortisone given after one week of life to reduce the incidence of the combined outcome of death and bronchopulmonary dysplasia in chronically ventilated preterm infants.
    Onderzoek naar de doeltreffendheid van hydrocortisone toegediend na de eerste levensweek ter reductie van het risico op de gecombineerde uitkomst van overlijden of bronchopulmonale dysplasie bij chronisch beademde premature pasgeborenen.
    E.2.2Secondary objectives of the trial
    Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalisation, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age.
    Secundaire uitkomsten zijn korte termijn effecten op de pulmonale toestand, bijwerkingen gedurende de hospitalisatie en lange termijn neurologische sequelen beoordeeld op de georrigeerde leeftijd van 2 jaar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preterm infants with a gestational age < 30 wks and/or birth weight < 1250 g, ventilator dependency at 7-14 days postnatal age, a respiratory index (RI = MAwP x FiO2) of ≥ 3.5 for more than 12 h/day for at least 48 hours, ensuring adequate oxygen saturation (85-95%) and pCO2 values in premature infants (5.0-7.5 kPa).
    E.4Principal exclusion criteria
    Infants with chromosomal defects (e.g. trisomy 13, 18, 21) or major congenital malformations that compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia), result in chronic ventilation (e.g. Pierre Robin sequence), or increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations) will be excluded.
    Also infants who received dexamethasone or hydrocortisone for the sole purpose of improving lung function and respiratory status prior to inclusion, will be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The dichotomous variable BPD free survival at 36 weeks PMA. BPD at 36 weeks PMA will be assessed according to the NIHCHD Consensus Statement defining normal oxygen saturation as 86%-94%. The severity of the BPD will be assessed as proposed by Jobe et.al.21, since the severity of BPD has a high association with neurodevelopmental sequelae.12 In case of supplemental oxygen delivery >21% and < 30% or low flow at 36 weeks PMA, the oxygen reduction test as described by Walsh et.al.21,49,50 should be preformed. A positive oxygen reduction test has a high correlation with the risk on discharge home with oxygen, the length of hospital stay, and pulmonary morbidity requiring hospital readmission during the first year of life.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 weeks postmenstrual age
    E.5.2Secondary end point(s)
    • treatment failure as defined in section 6.1.2
    • mortality at 28 days PNA, 36 weeks PMA and at hospital discharge
    • BPD at 28 days
    • failure to extubate 3, 7, 14 and 21 days after initiating therapy
    • duration of mechanical ventilation
    • use of “rescue treatment” with hydrocortisone outside the study protocol
    • total time on supplemental oxygen
    • length of hospital stay
    • incidence of hypertension, defined as systolic blood pressure > 2SD of standardized values used in the department
    • hyperglycemia requiring the use of insulin therapy
    • nosocomial infection, like sepsis, meningitis and pneumonia
    • hemodynamic significant patent ductus arteriosus for which medical intervention or surgical ligation is needed
    • necrotising enterocolitis (NEC), diagnosed at surgery, autopsy or by radiographic finding of pneumotosis intestinalis or hepatobiliary gas (Bell stage II)
    • gastrointestinal bleeding
    • isolated gastrointestinal perforation diagnosed on abdominal radiography
    • intraventricular haemorrhage (IVH) and/or periventricular leucomalacia (PVL), including grading on cerebral ultrasonography according to protocol defined by Ment et.al.51
    • retinopathy of prematurity, including grading following international classification52
    • weight gain, head circumference and length gain at 36 weeks PMA
    • long-term health and neurodevelopmental sequelae, assessed at 2 years CGA:
    o readmissions since first discharge home
    o weight, length and head circumference at 24 months c.a.
    o Bayley Scales of Infant Development III, Mental Developmental Index and Psychomotor Developmental Index
    o cerebral palsy and severity of cerebral palsy using gross motor function classification system
    o hearing loss requiring hearing aids
    o blindness
    E.5.2.1Timepoint(s) of evaluation of this end point
    - End of hospitalisation
    - neurodevelopment will be assessed at 2 years corrected age
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 last follow-up visit at 2 years corrected age of the last subject
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 100
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 100
    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
    preterm newborn infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    N/A
    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 Decision2011-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-01
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