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Clinical trials for Infant Respiratory Distress Syndrome

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
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    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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    20 result(s) found for: Infant Respiratory Distress Syndrome. Displaying page 1 of 1.
    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: 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: 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: 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 (Ongoing)
    Trial results: (No results available)
    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: 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: 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: 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: 2004-002312-29 Sponsor Protocol Number: INOT -27 Start Date*: 2005-01-10
    Sponsor Name:INO Therapeutics
    Full Title: The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants.
    Medical condition: Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10054933 LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) GB (Completed) DE (Completed) BE (Completed) ES (Completed) IT (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 (Ongoing)
    Trial results: (No results available)
    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: 2015-000253-21 Sponsor Protocol Number: CLA-CC10-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Therabron Therapeutics Inc.
    Full Title: Efficacy of recombinant human club (clara) cell 10kDa protein (CC10) administered to premature neonates with respiratory distress syndrome.
    Medical condition: Bronchopulmonary Dysplasia (BPD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005429-21 Sponsor Protocol Number: OPTIMIST-Aprotocol Start Date*: Information not available in EudraCT
    Sponsor Name:Menzies Research Institute Tasmania
    Full Title: Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure (CPAP)
    Medical condition: Infant respiratory distress syndrome, also known as hyaline membrane disease.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10020477 Hyaline membrane disease LLT
    Population Age: In utero, Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA SI (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001644-19 Sponsor Protocol Number: NUIG-2016-01 Start Date*: 2016-11-10
    Sponsor Name:National University of ireland Galway
    Full Title: A Randomised Placebo Controlled Trial of the effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
    Medical condition: Gestational Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004868 10018210 Gestational diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-014696-52 Sponsor Protocol Number: 17P-ES-003 Start Date*: 2009-12-31
    Sponsor Name:AMAG Pharma USA Inc.
    Full Title: A PHASE 3B, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF HYDROXYPROGESTERONE CAPROATE INJECTION, 250 MG/ML, VERSUS VEHICLE FOR THE PREVENTION OF PRETERM BIRTH IN WOMEN WITH A PREVIOUS SINGLETON ...
    Medical condition: Preterm birth
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10036594 Premature birth LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) ES (Completed) IT (Completed) CZ (Completed) BG (Completed)
    Trial results: (No results available)
    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: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
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