Flag of the European Union EU Clinical Trials Register Help

Clinical trials for neonatal

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   44359   clinical trials with a EudraCT protocol, of which   7382   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    905 result(s) found for: neonatal. Displaying page 1 of 46.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2009-018267-27 Sponsor Protocol Number: 64,185-203 Start Date*: 2010-06-08
    Sponsor Name:InfaCare Pharmaceutical Corporation
    Full Title: A 5-Year, Extension, Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202 "Un estudio ciego de seguimiento y ampliación de 5 años de ...
    Medical condition: Neonatal hyperbilirubinemia Hiperbilirrubinemia Neonatal
    Disease: Version SOC Term Classification Code Term Level
    12.1 10020580 Hyperbilirubinaemia neonatal LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005796-18 Sponsor Protocol Number: 03-217 Start Date*: 2009-07-21
    Sponsor Name:WKZ / UMC Utrecht
    Full Title: Does antenatal allopurinol during asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn?
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004943 Birth asphyxia LLT
    9.1 10014633 Encephalopathy neonatal LLT
    Population Age: In utero, Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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: 2009-014260-19 Sponsor Protocol Number: CH/2009/3187 Start Date*: 2010-01-29
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: A feasibility study of adding xenon to cooling therapy in babies at high risk of brain injury following poor condition at birth
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    12 10028923 Neonatal asphyxia LLT
    12 10028923 Neonatal asphyxia PT
    12 10028946 Neonatal hypoxia and asphyxia HLT
    12 10050081 Neonatal hypoxia LLT
    12 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-003224-31 Sponsor Protocol Number: 557087CE Start Date*: 2008-03-10
    Sponsor Name:AZIENDA OSPEDALIERA DI PADOVA
    Full Title: EFFECT OF SURFACTANT IN the CINETIC AND INFLAMMATION IN the NEW-BORN PRETERM WHIT RDS SINDROM.
    Medical condition: PREMATURY NEWBORN WITH WEIGTH = OR < TO 1250g IN ARTIFICIAL VENTILATION
    Disease: Version SOC Term Classification Code Term Level
    9.1 10038692 Respiratory distress syndrome in newborn LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-016653-17 Sponsor Protocol Number: FARM73452X Start Date*: 2010-04-13
    Sponsor Name:AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO
    Full Title: TREATMENT OF HYPOTENSION IN EXTREMELY PRETERM INFANTS: A MULTICENTER RANDOMIZED CONTROLLED TRIAL
    Medical condition: HYPOTENSION IN EXTREMELY PRETERM INFANTS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049223 LLT
    9.1 10049223 LLT
    9.1 10049223 LLT
    9.1 10049223 LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002923-13 Sponsor Protocol Number: 2535 Start Date*: 2021-04-15
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA OSPEDALI RIUNITI DI ANCONA
    Full Title: Indication for the exougenous surfactant administration to treat neonatal respiratory distress syndrome in the preterm infant: a single-center randomized phase 4 trial based on the comparison of tw...
    Medical condition: Neonatal respiratory distress syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10038690 Respiratory distress syndrome (neonatal) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-003611-21 Sponsor Protocol Number: 2013-003611-21 Start Date*: 2013-12-20
    Sponsor Name:Karolinska Institutet
    Full Title: Safety of fluconazol treatment of premature and full-term newborns - a study on interactions by NSAIDs with fluconazole in respect of pharmacodynamic endpoints with urinary excretion of vas...
    Medical condition: Fungal infection prophylaxis Patent ductus arteriosus
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    16.1 10021881 - Infections and infestations 10028924 Neonatal candida infection PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    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: 2015-003063-12 Sponsor Protocol Number: NEU-01-02-1A Start Date*: 2016-09-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: TIBC study: A multiple-centre Phase 2 trial comparing the efficacy of 2-Iminobiotin (2-IB) treatment to standard care in neonates with gestational age of ≥36 weeks with moderate to severe perinatal...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    19.0 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    19.0 100000004852 10021147 Hypoxic encephalopathy LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10022820 Intrauterine hypoxia and birth asphyxia LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10040441 Severe birth asphyxia LLT
    19.0 100000004852 10070512 Hypoxic-ischemic encephalopathy LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2015-003519-40 Sponsor Protocol Number: 03-CL-1202 Start Date*: 2016-02-18
    Sponsor Name:Windtree Therapeutics, Inc
    Full Title: A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE WITH RESPIRATOR...
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) IE (Completed) NL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-001331-22 Sponsor Protocol Number: CCD-1011-PR-0059 Start Date*: 2012-05-07
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A FIRST IN HUMAN CLINICAL STUDY ON THE SAFETY AND TOLERABILITY OF TWO ESCALATING SINGLE DOSES OF CHF 5633 (SYNTHETIC SURFACTANT) IN PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
    Medical condition: preterm neonates with Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    16.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    16.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-005624-26 Sponsor Protocol Number: 03-CL-1401 Start Date*: 2016-05-30
    Sponsor Name:Windtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)
    Full Title: A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 26 to 28 Weeks PMA.
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000106-32 Sponsor Protocol Number: 03-CL-1702 Start Date*: 2019-06-26
    Sponsor Name:Windtree Therapeutics, Inc.
    Full Title: A Multinational, Multicenter, Masked, Randomized, Parallel Group, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation versus nCPAP alone in Preterm Neonates 26 to 32 We...
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-004105-25 Sponsor Protocol Number: DM/PR/5000/002/04 Start Date*: 2007-02-12
    Sponsor Name:Chiesi Farmaceutici S p A
    Full Title: AN INTERNATIONAL, OPEN, RANDOMIZED, CONTROLLED STUDY TO EVALUATE THE EFFICACY OF COMBINING PROPHYLACTIC CUROSURF WITH EARLY NASAL CPAP VERSUS EARLY NASAL CPAP ALONE IN VERY PRETERM INFANTS AT RISK ...
    Medical condition: Neonatal Respiratory Distress Syndrome
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028974 Neonatal respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) IT (Completed) FR (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004265-25 Sponsor Protocol Number: 2-STEP Start Date*: 2015-04-15
    Sponsor Name:University Medical Centre Utrecht
    Full Title: 2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of ≥36 weeks with moderate to severe perin...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10003500 Asphyxia neonatal LLT
    19.0 100000004855 10004943 Birth asphyxia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-005371-15 Sponsor Protocol Number: DM/PR/5000/004/05 Start Date*: 2006-04-05
    Sponsor Name:CHIESI
    Full Title: A RANDOMIZED CONTROLLED STUDY TO EVALUATE THE EFFICACY OF A SUPPLEMENTAL DOSE OF CUROSURF IN PRE-TERM INFANTS ON MECHANICAL VENTILATION FOR RESPIRATORY DISTRESS SYNDROME RDS IN PREVENTING EXTUBAT...
    Medical condition: RDS - preterm infants
    Disease: Version SOC Term Classification Code Term Level
    6.1 10028974 PT
    Population Age: Preterm newborn infants Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-000896-30 Sponsor Protocol Number: Uni-Koeln-439 Start Date*: 2009-02-09
    Sponsor Name:University of Cologne
    Full Title: Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks
    Medical condition: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Oct 17 20:35:33 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA