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Clinical trials for Neonatal Diseases and Abnormalities

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    572 result(s) found for: Neonatal Diseases and Abnormalities. Displaying page 1 of 29.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2014-003436-39 Sponsor Protocol Number: P130904 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10028933 Neonatal diabetes mellitus PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000453-41 Sponsor Protocol Number: BMBF-Fz01KG1602 Start Date*: 2018-05-29
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety...
    Medical condition: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    20.1 10017947 - Gastrointestinal disorders 10055667 Necrotising enterocolitis neonatal PT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071101 Primary apnoea of premature newborns LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-017434-45 Sponsor Protocol Number: 64,185-202 Start Date*: Information not available in EudraCT
    Sponsor Name:InfaCare Pharmaceutical Corporation
    Full Title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with Hyperbilirubinemia
    Medical condition: Neonatal hyperbilirubinemia Hiperbilirubinemia neonatal
    Disease: Version SOC Term Classification Code Term Level
    14.0 10019805 - Hepatobiliary disorders 10020580 Hyperbilirubinaemia neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020797-41 Sponsor Protocol Number: NEMO1-08NR26 Start Date*: 2010-11-16
    Sponsor Name:Only for Children Pharmaceuticals
    Full Title: NEMO-1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.
    Medical condition: Neonatal Seizures in Hypoxic Ischemic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029205 - Nervous system disorders 10061197 Neonatal seizures LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) FI (Prematurely Ended) GB (Prematurely Ended) SE (Prematurely Ended) FR (Ongoing) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004417-16 Sponsor Protocol Number: 5022LC Start Date*: Information not available in EudraCT
    Sponsor Name:St. Elisabeth Hospital
    Full Title: CEFTRIAXONE NEONATAL THERAPY: A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA
    Medical condition: Hyperbilirubinemia
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000565-36 Sponsor Protocol Number: 38/2018 Start Date*: 2018-06-05
    Sponsor Name:University of Oulu
    Full Title: Paracetamol and ibuprofen/indomethacin in closing persistent ductus arteriosus
    Medical condition: Patent ductus arteriosus of a premature infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000566-11 Sponsor Protocol Number: 39-2018 Start Date*: 2018-06-05
    Sponsor Name:University of Oulu
    Full Title: Extremely low gestational age infants' PARAcetamol Study
    Medical condition: Open ductus arteriosus of a premature infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002502-74 Sponsor Protocol Number: NEU-01-02-01 Start Date*: 2012-02-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: A multi-centre, randomised, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of 2-iminobiotin (2-IB) in neonates with gestational...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-005091-26 Sponsor Protocol Number: SANNI-project:02 Start Date*: 2018-02-13
    Sponsor Name:Skåne University Hospital
    Full Title: Clonidine for analgesia to preterm infants during neonatal intensive care – a prospective pharmacokinetic/pharmacodynamic/pharmacogenetic observational study. Cohort 2 in The SANNI project.
    Medical condition: Sick preterm infants undergoing neonatal intensive care.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-020103-70 Sponsor Protocol Number: 1 Start Date*: 2012-08-14
    Sponsor Name:University of Tartu
    Full Title: Pharmacokinetics of intravenous phenobarbital and lidocaine in the treatment of neonatal seizures of term neonates requireing therapeutic hypothermia
    Medical condition: Neonatal seizures
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000222-19 Sponsor Protocol Number: H2020-PHC-18-2015-667224 Start Date*: 2017-08-02
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome – a blinded randomized placebo-controlled parallel group multicenter trial for superiori...
    Medical condition: Perinatal Asphyxia, hypoxic-ischemic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    20.0 10029205 - Nervous system disorders 10014633 Encephalopathy neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) NO (Trial now transitioned) ES (Ongoing) FI (Trial now transitioned) EE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) PT (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002506-37 Sponsor Protocol Number: SANNI-project:03 Start Date*: 2020-01-08
    Sponsor Name:Region Skane
    Full Title: Dexmedetomidine for analgosedation to newborn infants during neonatal intensive care – a prospective pharmacokinetic/ pharmacodynamic/ pharmacogenetic observational study.Cohort 3 in The SANNI Pr...
    Medical condition: Sick newborn infants in need of intensive care.
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003556-31 Sponsor Protocol Number: SHP-607-201 Start Date*: 2015-02-10
    Sponsor Name:Premacure AB, A Member of the Shire Group of Companies
    Full Title: Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care
    Medical condition: Retinopathy of Prematurity (ROP)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003490-15 Sponsor Protocol Number: CACZ885D2308 Start Date*: 2016-04-14
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated P...
    Medical condition: Cryopyrin-associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome Neonatal Onset Multisystem Inflammatory Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10064570 Familial cold autoinflammatory syndrome PT
    19.0 10010331 - Congenital, familial and genetic disorders 10064574 NOMID LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    19.0 10010331 - Congenital, familial and genetic disorders 10064569 Muckle-Wells syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-002109-24 Sponsor Protocol Number: 09122019 Start Date*: 2019-08-01
    Sponsor Name:Tampere University Hospital
    Full Title: Oral Disodiumpyrophosphate (Na2H2PPi) Absorption in Pseudoxanthoma Elasticum
    Medical condition: Pseudoxanthoma elasticum
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004898-14 Sponsor Protocol Number: MgSO4-konc Start Date*: 2018-04-03
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: See down below.
    Medical condition: Please see below
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002924-35 Sponsor Protocol Number: APHP180592 Start Date*: 2021-01-18
    Sponsor Name:ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    Full Title: Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir
    Medical condition: Step 1: Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP Step 2: Maternal daily administration of 240 or 480 milligrams of letermovir (1x240 mg-ta...
    Disease:
    Population Age: Children, Under 18, Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001066-10 Sponsor Protocol Number: SP0968 Start Date*: 2021-09-06
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
    Medical condition: Electroencephalographic Neonatal Seizures (ENS)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-005475-41 Sponsor Protocol Number: MLX Start Date*: 2014-11-05
    Sponsor Name:UZ Brussel
    Full Title: Sulfamethoxazole treatment of primary PREPL deficiency
    Medical condition: Hypotonia-cystinuria syndrome and isolated PREPL deficiency.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002845-12 Sponsor Protocol Number: NEOCIRC-001 Start Date*: 2013-12-03
    Sponsor Name:SERMAS (Hospital la Paz)
    Full Title: An international multicentre open-label comparative therapeutic exploratory trial to investigate the role of a new neonatal formulation of dobutamine in the treatment of haemodynamic insufficiency ...
    Medical condition: babies with evidence of haemodynamic insufficiency within 72 hours after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted) GB (Completed) HU (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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