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Clinical trials for Neonatal infection

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   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).

    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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    92 result(s) found for: Neonatal infection. Displaying page 1 of 5.
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    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: 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: 2008-008899-14 Sponsor Protocol Number: LWH0776 Start Date*: 2009-06-25
    Sponsor Name:Liverpool Women's NHS Foundation Trust
    Full Title: Standardised, Concentrated, Additional Macronutrients, Parenteral (SCAMP) nutrition in very preterm infants: a phase IV randomised controlled study of macronutrient intake, growth and implications ...
    Medical condition: Prematurity
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 2016-004447-36 Sponsor Protocol Number: ZonMw848015005 Start Date*: 2017-06-23
    Sponsor Name:Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde
    Full Title: INTRAVENOUS-TO-ORAL ANTIBIOTIC SWITCH THERAPY FOR SUSPECTED NEONATAL BACTERIAL INFECTIONS: CLINICAL EFFICACY, SAFETY AND COST-EFFECTIVENESS
    Medical condition: Neonatal probable bacterial infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002020-33 Sponsor Protocol Number: OZBS32.18194 Start Date*: 2019-12-10
    Sponsor Name:Erasmus University Medical Center
    Full Title: Pentoxifylline dose optimization in neonatal sepsis.
    Medical condition: Neonatal late onset sepsis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-004079-17 Sponsor Protocol Number: COMBATARF Start Date*: 2023-03-20
    Sponsor Name:Rigshospitalet
    Full Title: Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in mechanically ventilated patients with infectious pulmonary endotheliopathy – a multicentre randomized, placebo-controlled, b...
    Medical condition: Infectious pulmonary endotheliopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038696 Respiratory failure (excl neonatal) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000535-23 Sponsor Protocol Number: HCB/2021/0060 Start Date*: 2022-06-20
    Sponsor Name:Barcelona Institute for Global Health (ISGlobal)
    Full Title: Efficacy of low dose acetylsalicylic acid in preventing adverse maternal and perinatal outcomes in SARS-CoV-2 infected pregnant women
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001726-22 Sponsor Protocol Number: COLIGROW Start Date*: 2022-12-12
    Sponsor Name:Dr. Ignacio Herraiz García
    Full Title: COok's ballon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study).
    Medical condition: Induction of term pregnancies with fetal growth restriction.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005738-12 Sponsor Protocol Number: LIPSTIC.V.01 Start Date*: 2013-03-27
    Sponsor Name:Alder Hey Children's NHS Foundation Trust
    Full Title: Liverpool Pharmacokinetic/pharmacodynamics study of teicoplanin in children (LIPSTIC).
    Medical condition: Gram-positive bacterial infection: late-onset neonatal sepsis, central line-associated blood stream infection, ventilator-associated pneumonia.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002148-15 Sponsor Protocol Number: 201500214815 Start Date*: 2017-06-01
    Sponsor Name:Bethesda Diabetes research Center (BDRC)
    Full Title: Pregnancy Outcomes: Effects of Metformin Study (POEM Study) a long term randomized controlled parallel group study in gestational diabetes mellitus
    Medical condition: Gestational diabetes mellitus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002232-41 Sponsor Protocol Number: P140310 Start Date*: 2015-11-10
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004482-14 Sponsor Protocol Number: P160917 Start Date*: 2019-08-14
    Sponsor Name:ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    Full Title: Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation: a double-blinded randomized controlled trial
    Medical condition: Pregnant women with PPROM at 22 to 33 weeks gestation
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-004692-19 Sponsor Protocol Number: 963 Start Date*: 2007-12-19
    Sponsor Name:Biotest AG
    Full Title: Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study...
    Medical condition: Congenital CMV infection after primary CMV infection during pregnancy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003326-41 Sponsor Protocol Number: 200719 Start Date*: 2016-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000026-30 Sponsor Protocol Number: ABR35278 Start Date*: 2013-05-08
    Sponsor Name:Academic medical centre
    Full Title: Induction of Labour with a Foley catheter or oral Misoprostol at Term
    Medical condition: Induction of labour at term
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004868 10023540 Labor induced LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000735-80 Sponsor Protocol Number: 2010-382 Start Date*: 2011-05-16
    Sponsor Name:Lene Drasbek Huusom
    Full Title: Administration of antenatal magnesium sulphate for prevention of cerebral palsy in preterm infants (MASP-STUDY)
    Medical condition: Moderate to severe cerebral palsy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005397-34 Sponsor Protocol Number: Issue1 Start Date*: 2012-02-24
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: Xenon and cooling therapy in babies at high risk of brain injury following poor condition at birth: Randomised pilot study. (CoolXenon2 study)
    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
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10028946 Neonatal hypoxia and asphyxia HLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001007-72 Sponsor Protocol Number: 80-84800-98-41027 Start Date*: 2017-07-06
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).
    Medical condition: Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-000608-14 Sponsor Protocol Number: 1.0/170119 Start Date*: Information not available in EudraCT
    Sponsor Name:Tartu University Hospital
    Full Title: Prospective validation of individualized Bayesian dose optimization tool DosOpt for Vancomycin treatment in neonates.
    Medical condition: In neonatal population wide inter-and intra-individual variability of pharmacokinetics makes extremely difficult to ensure optimal exposure of vancomycin with standard regimens. On average >50% of ...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Ongoing)
    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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