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Clinical trials for Newborn infant

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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    85 result(s) found for: Newborn infant. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    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: 2017-000583-15 Sponsor Protocol Number: 60858 Start Date*: 2017-08-11
    Sponsor Name:Leiden University Medical Center
    Full Title: Randomized controlled trial on the use of EPO to reduce top-up transfusions in neonates with red blood cell alloimmunization treated with intrauterine transfusions
    Medical condition: Hemolytic disease of the newborn due to red blood cell alloimmunization
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10019513 Hemolytic disease of fetus or newborn, due to isoimmunization LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-015659-26 Sponsor Protocol Number: 2009-015659-26 Start Date*: 2010-01-22
    Sponsor Name:Karolinska Institutet
    Full Title: Cortical and hormonal stress responses to pain management with morphine in standard clinical dosage
    Medical condition: Neonatal pain
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056350 Pain management LLT
    12.1 10022519 Intensive care LLT
    12.1 10029392 Newborn LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    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: 2011-003473-29 Sponsor Protocol Number: Uni-Koeln-1488 Start Date*: 2012-11-19
    Sponsor Name:University of Cologne
    Full Title: Trial on treatment with inhaled furosemide of preterm and term neonates with transient tachypnoea
    Medical condition: In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10044403 Transient tachypnoea of the newborn PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (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: 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: 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
    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: 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: 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: 2013-005572-17 Sponsor Protocol Number: 20132312 Start Date*: 2014-05-21
    Sponsor Name:Erasmus Medical Center
    Full Title: Optimizing propofol dosing for (preterm) newborn infants that need endotracheal intubation
    Medical condition: Sedation for endotracheal intubation in newborns of different ages at the neonatal intensive care unit
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004869 10029392 Newborn LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-007550-66 Sponsor Protocol Number: Emulipid Start Date*: 2008-02-21
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Lipidic emulsions influence on immune response of pre-term VLBW newborns treated with total parenteral nutrition
    Medical condition: very low birth weight newborn
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036590 Premature baby LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-004958-42 Sponsor Protocol Number: MOM-M281-003 Start Date*: 2019-01-11
    Sponsor Name:Momenta Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease ...
    Medical condition: Early onset Severe Hemolytic Disease of the fetus and newborn (HDFN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10019512 Hemolytic disease due to Rh isoimmunization of fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) NL (Completed) SE (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004547-36 Sponsor Protocol Number: CCD-01534CA1-01 Start Date*: 2017-03-16
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY ...
    Medical condition: Mild to moderate respiratory distress syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004855 10038690 Respiratory distress syndrome (neonatal) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended) AT (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003466-39 Sponsor Protocol Number: Protocol_MAMA_studie_22/05/2018 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Antwerp
    Full Title: Pertussis immunization during pregnancy: assessment of the role of maternal antibodies on immune responses in term and preterm infants (the MAMA study)
    Medical condition: The effect of pertussis vaccination during pregnancy on the immune response after infant and childhood vaccinations in term and preterm infants.
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002648-26 Sponsor Protocol Number: S54472 Start Date*: 2013-10-16
    Sponsor Name:UZ Leuven
    Full Title: Exploratory Propofol Dose Finding Study In Neonates.
    Medical condition: Investigation of the most effective intravenously administered single propofol dose for successful INSURE prodecure and for (semi-)elective intubation of neonates in non-INSURE conditions (e.g. sur...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004869 10028977 Neonate LLT
    16.0 10042613 - Surgical and medical procedures 10067450 Endotracheal intubation PT
    16.0 10042613 - Surgical and medical procedures 10049124 Sedation during medical procedure LLT
    16.0 10022891 - Investigations 10061134 Drug level therapeutic PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    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 (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
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