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    Summary
    EudraCT Number:2021-004890-29
    Sponsor's Protocol Code Number:FIT-PIV
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-03-13
    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 number2021-004890-29
    A.3Full title of the trial
    A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Een multicenter, dubbelblinde, gerandomiseerde, tweearmige, parallelgroep, placebogecontroleerde studie om de werkzaamheid en veiligheid van ELGN-2112 op darm malabsorptie te onderzoeken bij te vroeg geboren baby's.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study that will be conduced in different clinical sites, in which nor the patient neither the doctors will know the treatment given to patient, with 2 different group in which the patients will be assigned randomly, controlled with respect to placebo, that has the aim to estabilish the efficacy and the safety of ELGN2112 on the incapability of preterm baby to absorb sufficient nutrients, a condition known as intestinal malabsorption
    studie die wordt uitgevoerd in verschillende klinische locaties, waarbij noch de ouders/patiënt noch de artsen de behandeling weten die aan het kind wordt gegeven, met 2 groepen waarin de kinderen willekeurig worden toegewezen, gecontroleerd met betrekking tot placebo, die tot doel heeft de werkzaamheid en veiligheid van ELGN2112 vaststellen voor het onvermogen van premature kinderen om voldoende voedingsstoffen op te nemen, een aandoening die bekend staat als intestinale malabsorptie
    A.3.2Name or abbreviated title of the trial where available
    FIT-PIV
    FIT-PIV
    A.4.1Sponsor's protocol code numberFIT-PIV
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/079/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELGAN Pharma
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportELGAN Pharma
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationELGAN Pharma
    B.5.2Functional name of contact pointDonna Ehrenberg
    B.5.3 Address:
    B.5.3.1Street Address13 Wadi El Haj 13
    B.5.3.2Town/ cityNazareth
    B.5.3.3Post code17111
    B.5.3.4CountryIsrael
    B.5.4Telephone number+97246098626
    B.5.6E-maildonna@elganpharma.com
    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 No
    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 nameELGN-2112
    D.3.2Product code ELGN-2112
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNELGN-2112
    D.3.9.2Current sponsor codeELGN-2112
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN INSULIN ISOPHANE BIPHASIC
    D.3.9.4EV Substance CodeSUB77116
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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) 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 Yes
    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 oral solution
    D.8.4Route of administration of the placeboEnteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intestinal Malabsorption in Preterm Infants
    Intestinale malabsorptie bij prematuren
    E.1.1.1Medical condition in easily understood language
    digestive tract (oesophagus, stomach and intestines)in preterm infants is not fully developed. These infants are unable to absorb sufficient nutrients, which is described as intestinal malabsorption.
    spijsverteringskanaal (slokdarm, maag en darmen) bij premature kinderen is niet volledig ontwikkeld. Deze kinderen kunnen onvoldoende voedingsstoffen opnemen, dit is intestinale malabsorptie.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032413
    E.1.2Term Other preterm infants, 750-999 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032407
    E.1.2Term Other preterm infants, 1,250-1,499 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032409
    E.1.2Term Other preterm infants, 1,750-1,999 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032411
    E.1.2Term Other preterm infants, 2,500+ grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032415
    E.1.2Term Other preterm infants, unspecified {weight}
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032412
    E.1.2Term Other preterm infants, 500-749 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032406
    E.1.2Term Other preterm infants, 1,000-1,249 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032408
    E.1.2Term Other preterm infants, 1,500-1,749 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032410
    E.1.2Term Other preterm infants, 2,000-2,499 grams
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.
    Om de werkzaamheid van ELGN-2112 te beoordelen in vergelijking met placebo op intestinale malabsorptie bij prematuren, gemeten aan de hand van de tijd tot volledige enterale voeding.
    E.2.2Secondary objectives of the trial
    1. effect of ELGN-2112 compared to placebo on number of days until full wean off PN.2.effect of ELGN-2112 compared to placebo on the n of days to discharge home;To compare ELGN-2112 to placebo with respect to the following:3. Incidence and severity of NEC in infants born at 26-28 GAM;4. %of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment;5. N of days to 120 ml/kg/day for 3consecutive days;6. Number of days until PN wean off(time to amino acids and lipids withdrawal);7. %of infants weaned off PN within 4, 6, and 8 days from initiation of treatment;8. % enteral/ parenteral feedings from total nutrition over time;9. N of days to discharge from primary hospital;10. Anthropometrics;11. % of infants with culture proven nosocomial sepsis;12. %of infants experiencing one of the adverse events of relevance (NEC, Infections, Death);13.ROP activity score at 30-36 weeks PMA; To compare the safety of treatment of ELGN-2112 to placebo in preterm infants.
    1. effect van ELGN-2112 tov placebo op het aantal dagen tot volledige afbouw PN.2.effect van ELGN-2112 in vergelijking met placebo op de n dagen tot ontslag naar huis; rekening houdend met: 3. Incidentie en ernst van NEC bij zuigelingen geboren op 26-28 GAM;4. % van kinderen dat volledige enterale voeding bereikt binnen 6, 8 en 10 dagen na start van de behandeling;5. N dagen tot 120 ml/kg/dag gedurende 3 opeenvolgende dagen;6. N dagen tot het afbouwen van PN (tijd tot onttrekking van aminozuren en lipiden);7. % van kinderen stopt met PN binnen 4, 6 en 8 dagen na begin van behandeling;8. % enterale/parenterale voeding tov totale voeding in loop van tijd;9. N dagen tot ontslag uit ziekenhuis;10. Antropometrie;11. % kinderen met in kweek bewezen nosocomiale sepsis;12. % van kinderen met een relevante bijwerking (NEC,Infectie,dood); 13.ROP-activiteitsscore bij 30-36 weken PMA; Om de veiligheid van ELGN-2112 behandeling te vergelijken met placebo bij prematuren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female pre-term infants 26 and up to 32 weeks gestation (32 weeks + 0 day maximum). Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound*.
    2. Birth weight ≥ 500g.
    3. Singleton, or twin birth.
    4. Postnatal age up through and including Day 5 (up to 120 hours post birth).
    5. Fraction of inspired oxygen ≤ 0.60 at enrolment.
    6. Infants must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require blood pressure support via a central line.
    7. Infant is able to tolerate enteral feed.
    8. Infant is expected to wean off PN at the primary hospital.
    9. Informed consent form (ICF) signed by parents or legal guardian.
    10. In the Investigator’s opinion, the infant is able to comply with the study procedures and sufficiently stable to partake in the trial to completion.
    * If both exist and difference > 2 weeks, based on early antenatal ultrasound
    1. Prematuur geboren mannelijke of vrouwelijke kinderen van 26 tot 32 weken zwangerschap (maximaal 32 weken + 0 dagen). Matching zwangerschapsduur (±2 weken) tussen data van de moeder en/of vroege prenatale echografie*.
    2. Geboortegewicht ≥ 500g.
    3. Singleton- of tweelinggeboorte.
    4. Postnatale leeftijd tot en met dag 5 (tot 120 uur na de geboorte).
    5. Fractie ingeademde zuurstof ≤ 0,60 bij inschrijving.
    6. Kinderen moeten op het moment van inschrijving blijk geven van cardiovasculaire stabiliteit en zijn onstabiel als ze bloeddrukondersteuning nodig hebben via een centrale lijn.
    7. Kind kan enterale voeding verdragen.
    8. Verwachting dat kinderen PN afbouwen in het primaire ziekenhuis.
    9. Formulier voor geïnformeerde toestemming (ICF) ondertekend door ouders en/of wettelijke voogd.
    10. Naar de mening van de onderzoeker is het kind in staat om de studieprocedures na te leven en voldoende stabiel om de studie te volbrengen.
    * Indien beide bestaan en verschil > 2 weken, op basis van vroege prenatale echografie
    E.4Principal exclusion criteria
    1. Infant is consuming more than 100 ml/kg/day enterally at study entry
    2. Infant is not dependent on any parenteral amino acids/lipids as nutrition
    3. Major congenital malformation (e.g., Infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment).
    4. Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart.
    5. Confirmed necrotizing enterocolitis (NEC).1
    6. Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
    7. suspected or confirmed Hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.
    8. Any systemic insulin administration at randomization.
    9. Never anything per os (NPO) until 120 hrs post-birth for any reason.
    10. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
    11. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
    12. Participation in another interventional clinical study that may interfere with the primary and secondary outcomes of this trial.
    1. Het kind consumeert meer dan 100 ml/kg/dag enteraal bij binnenkomst in het onderzoek
    2. Het kind is niet afhankelijk van parenterale aminozuren/lipiden als voeding
    3. Ernstige aangeboren afwijking (bijv. kinderen met een genetische, metabole en/of endocriene stoornis die vóór de inschrijving werd gediagnosticeerd).
    4. Intra-uteriene groeirestrictie (IUGR) gedefinieerd als gewicht voor zwangerschapsduur van minder dan het derde percentiel volgens de Fenton-groeigrafiek voor prematuren.
    5. Bevestigde necrotiserende enterocolitis (NEC).
    6. Maternale diabetes (type I/II of zwangerschapsdiabetes) die insuline nodig heeft tijdens de zwangerschap of bij moeders met een medische voorgeschiedenis.
    7. vermoede of bevestigde hyperinsulinemie die bij randomisatie een glucosetoediening van meer dan 12 mg/kg/min vereist.
    8. Elke systemische insulinetoediening bij randomisatie.
    9. Nooit iets per os (NPO) tot 120 uur na de geboorte om welke reden dan ook.
    10. Hart- en borstcompressie of reanimatiemedicatie die tijdens de bevalling aan het kind wordt gegeven.
    11. Kinderen met een risico op significante GI-complicaties, zoals tweeling-naar-tweelingtransfusiesyndroom (TTTS) of monochoriale mono-amniotische tweelingen.
    12. Deelname aan een andere interventionele klinische studie die de primaire en secundaire uitkomsten van deze studie kan beïnvloeden.
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of days to achieve full enteral feeding, defined as the first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days.
    Aantal dagen voor volledige enterale voeding, gedefinieerd als de eerste dag waarop het premature kind in staat is om gedurende drie opeenvolgende dagen ten minste 150 ml/kg/dag enteraal te voeden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the study (first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days)
    tijdens het onderzoek (eerste dag waarop het premature kind in staat is om enterale voeding te krijgen van ten minste 150 ml/kg/dag gedurende drie opeenvolgende dagen)
    E.5.2Secondary end point(s)
    1. Number of days until wean off PN (total cessation)
    2. Number of days from randomization to discharge home
    3. Incidence and severity of Necrotizing Enterocolitis (NEC)
    o Incidence of modified Bell’s stage grade >=2 of Necrotizing Enterocolitis (NEC) in infants born at 26-28 weeks GA.
    o Distribution of severity of Necrotizing Enterocolitis (NEC) according to modified Bell’s staging in infants born at 26-28 weeks GA who experienced NEC.
    o Incidence of modified Bell’s stage grade >=2 of Necrotizing Enterocolitis (NEC) in the entire study population.
    o Distribution of severity of Necrotizing Enterocolitis (NEC) according to modified Bell’s staging in infants who experienced NEC in the entire study population.
    4. Percentage of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment.
    5. Number of days to 120 ml/kg/day for three consecutive days
    6. Number of days until PN wean off (time to amino acids and lipids withdrawal)
    7. Percentage of infants weaned off PN within 4, 6, and 8 days from initiation of treatment
    8. Percent enteral/ parenteral feedings from total nutrition over time
    9. Number of days to discharge from primary hospital.
    10. Anthropometrics
    11. Number of events of culture proven nosocomial Sepsis
    12. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death)
    13. Retinopathy of prematurity (ROP) activity score at 30-36 weeks PMA
    1. Aantal dagen tot afbouw PN (totale stopzetting)
    2. Aantal dagen vanaf randomisatie tot ontslag naar huis
    3. Incidentie en ernst van necrotiserende enterocolitis (NEC)
    o Incidentie van gemodificeerde fasegraad van Bell> = 2 van necrotiserende enterocolitis (NEC) bij kinderen geboren op 26-28 weken GA.
    o Verdeling van de ernst van necrotiserende enterocolitis (NEC) volgens gemodificeerde Bell's-stadiëring bij kinderen geboren op 26-28 weken GA die NEC doormaakten.
    o Incidentie van gemodificeerde fasegraad van Bell> = 2 van necrotiserende enterocolitis (NEC) in de gehele onderzoekspopulatie.
    o Verdeling van de ernst van necrotiserende enterocolitis (NEC) volgens gemodificeerde Bell's-stadiëring bij kinderen die NEC doormaakten in de gehele onderzoekspopulatie.
    4. Percentage kinderen dat volledige enterale voeding bereikt binnen 6, 8 en 10 dagen na aanvang van de behandeling.
    5. Aantal dagen tot 120 ml/kg/dag gedurende drie opeenvolgende dagen
    6. Aantal dagen tot het afbouwen van PN (tijd tot onttrekking van aminozuren en lipiden)
    7. Percentage kinderen dat binnen 4, 6 en 8 dagen na aanvang van de behandeling van PN is gevoed
    8. Percentage enterale / parenterale voedingen van totale voeding in de loop van de tijd
    9. Aantal dagen tot ontslag uit het primaire ziekenhuis.
    10. Antropometrie
    11. Aantal voorvallen van in cultuur bewezen nosocomiale sepsis
    12. Percentage proefpersonen dat een van de relevante bijwerkingen ervaart (NEC, Infections, Death)
    13. Retinopathie van prematuriteit (ROP) activiteitsscore bij 30-36 weken PMA
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the study
    tijdens de studie
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    United States
    Austria
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    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 patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.1Number of subjects for this age range: 360
    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: 360
    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.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    newborn infants
    pasgeboren kinderen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 360
    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 period
    The infants will return to the clinical site for a follow-up visit at 6 months, 12 months, and 24 months corrected age.
    navolgperiode
    De kinderen zullen terugkeren naar het klinisch centrum voor een vervolgbezoek op 6 maanden, 12 maanden en 24 maanden van de juiste leeftijd.
    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 Decision2023-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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