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Clinical trials for Neonatology

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    19 result(s) found for: Neonatology. Displaying page 1 of 1.
    EudraCT Number: 2005-001269-32 Sponsor Protocol Number: 01/05 Start Date*: 2005-12-27
    Sponsor Name:Universitätskinderklinik Innsbruck
    Full Title: Clinical trial on skin care in Neonatology. A comparison between two skin care products and no skin care
    Medical condition: Normal skin care of newborns
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005568-24 Sponsor Protocol Number: NL47657-044-14 Start Date*: 2014-05-28
    Sponsor Name:Medisch Spectrum Twente
    Full Title: The reduction of Apneas in Preterm Infants: Low-Flow versus Caffeine
    Medical condition: Apnea Of Prematurity
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001551-11 Sponsor Protocol Number: Iloprost Start Date*: 2004-09-22
    Sponsor Name:Lund University Hospital
    Full Title: Behandling av förhöjt pulmonellt arteriellt tryck med inhalerad iloprost
    Medical condition: Nyfödda barn som är i behov av respiratorvård pga RDS, mekoniumaspiration eller primär lunghypertension
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001912-20 Sponsor Protocol Number: 48431 Start Date*: 2018-02-26
    Sponsor Name:University Medical Center Utrecht, The Netherlands
    Full Title: Adult mesenchymal stem cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stem cells IntraNasally)
    Medical condition: Perinatal arterial Ischemic Stroke (PAIS)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000147-13 Sponsor Protocol Number: I15014 Start Date*: 2016-06-21
    Sponsor Name:CHU de LIMOGES
    Full Title: Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term?
    Medical condition: cervix ripening
    Disease: Version SOC Term Classification Code Term Level
    19.0 10042613 - Surgical and medical procedures 10073175 Induction of cervix ripening PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-001583-52 Sponsor Protocol Number: Intu Start Date*: 2004-09-22
    Sponsor Name:Lund University Hospital
    Full Title: Balanced anestesia for intubation of newborn premature infants – a randomized intervention study Balanserad anestesi för intubation av nyfödda prematura barn – en randomiserad interventionsstudie
    Medical condition: Respiratory insufficiency in prematrue infants requiring ventilatory assistance and therefore intubation. Premedication before intubation.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004526-33 Sponsor Protocol Number: PDARCT1 Start Date*: Information not available in EudraCT
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score
    Medical condition: Patent Ductus Arteriosus
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    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: 2018-003626-91 Sponsor Protocol Number: CAFSP01 Start Date*: 2019-04-09
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
    Full Title: CAFFEINE TREATMENT IN DELIVERY ROOM FOR VERY PRETERM INFANTS : A FEASIBILITY STUDY
    Medical condition: 25+0-29+6 gestational age preterm infants at risk of respiratory distress syndrome with no need of mechanical ventilation in delivery room.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004868 10021734 Infant premature LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002974-11 Sponsor Protocol Number: IBU24h-EchoG Start Date*: 2016-11-10
    Sponsor Name:María Carmen Bravo Laguna
    Full Title: Phase III, randomized, multicenter, double-blind clinical trial to evaluate two echo-guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus: impact on intestinal p...
    Medical condition: patent ductus arteriosus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012203-26 Sponsor Protocol Number: Grand_Award_Health-F5_2009-223060 Start Date*: 2009-11-19
    Sponsor Name:University Children's Hospital, Department of Neonatology
    Full Title: Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
    Medical condition: Survival of Extremely Low Birth Weight (ELBW) infants has improved in recent decades but Bronchopulmonary Dysplasia (BPD) remains a major health care problem. BPD is a chronic lung disease that occ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) FR (Completed) EE (Completed) CZ (Completed) BE (Completed) GR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001393-16 Sponsor Protocol Number: SHP607-202 Start Date*: 2019-06-21
    Sponsor Name:Premacure AB
    Full Title: A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Co...
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Restarted) SE (Temporarily Halted) FR (Ongoing) DE (Restarted) PT (Restarted) ES (Temporarily Halted) FI (Temporarily Halted) NL (Restarted) PL (Prematurely Ended) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003666-41 Sponsor Protocol Number: MEC2020-0078 Start Date*: 2020-04-21
    Sponsor Name:Erasmus MC University Medical Center
    Full Title: Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial.
    Medical condition: Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Co...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077323 Infantile mixed apnea LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003603-61 Sponsor Protocol Number: 002 Start Date*: 2017-07-19
    Sponsor Name:
    Full Title: Clinical trial on the administration of 3 doses of betamethasone (12 mg) in 18 hours apart in twin pregnancy patients with threatened preterm birth treated by Atosiban, rather than 2 doses of betam...
    Medical condition: Premature delivery in twin pregnancies
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004868 10028244 Multiple pregnancy affecting fetus or newborn LLT
    19.1 100000004868 10036564 Pregnancy multiple LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000649-30 Sponsor Protocol Number: P150905 Start Date*: 2016-09-29
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Impact of the administration of Fludrocortisone the fluid and electrolyte balance in great premature. Pilot study.
    Medical condition: Great prematurity
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10053593 Premature baby 26 to 32 weeks LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-003358-27 Sponsor Protocol Number: HUM06-037 Start Date*: 2008-05-02
    Sponsor Name:Center of Pediatrics and Neonatology, Asklepios Clinic Sankt Augustin
    Full Title: Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab
    Medical condition: Juvenile ankylosing spondylitis
    Disease: Version SOC Term Classification Code Term Level
    10 10002556 LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-003415-29 Sponsor Protocol Number: 2.0 Start Date*: 2023-04-03
    Sponsor Name:Leiden University Medical Centre
    Full Title: The effect of antenatal acetaminophen administration on breathing effort of premature infants at birth: a pilot study
    Medical condition: Pregnant women expected to deliver between 24 and 30 weeks' gestation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10033762 Paracetamol LLT
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003108-56 Sponsor Protocol Number: PULMESCEL-1 Start Date*: 2018-02-09
    Sponsor Name:Fundación para la investigación biomédica del Hospital Ramón y Cajal
    Full Title: Clinical Trial: Feaseability and security of the treatment of Bronchopulmonary Dysplasia in preterm babies with expanded umbilical cord allogenic fetal mesenchymal stem cells.
    Medical condition: 10 preterm babies under 28 weeks of gestational age and under 1250 grams of weight, at high risk of presenting pulmonary damage.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002875-25 Sponsor Protocol Number: NEO-CIRC-003 Start Date*: 2018-07-24
    Sponsor Name:SERMAS-FIBHULP
    Full Title: An international multicentre randomized placebo-controlled, double blind three arm trial to investigate the efficacy of dobutamine with two different starting doses in the treatment of haemodynamic...
    Medical condition: Haemodynamic insufficiency (Haemodynamic insufficiency after birth is commonly seen in babies born prematurely. The condition has a significant clinical impact. A final common pathway is seen but ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10009196 Circulatory failure neonatal PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (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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