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Clinical trials for Preterm birth

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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    155 result(s) found for: Preterm birth. Displaying page 3 of 8.
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    EudraCT Number: 2006-006912-31 Sponsor Protocol Number: AMV-12_12_2006 Start Date*: Information not available in EudraCT
    Sponsor Name:Universitätsklinikum Schleswig-Holstein
    Full Title: Vereidung maschineller Beatmung bei sehr kleinen Frühgeborenen - Avoid mechanical ventilation (The AMV-Trial)
    Medical condition: Respiratory distress syndrom of preterm infants (ICD 10: P22.0)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000612-34 Sponsor Protocol Number: EpoRepair Start Date*: 2015-12-15
    Sponsor Name:UniversitätsSpital Zürich
    Full Title: Erythropoietin for the repair of cerebral injury in very preterm infants, a randomized, double-blind, placebo-controlled, prospective, and multicenter clinical study
    Medical condition: 1 out of 100 children born extremely early, or more than 8 weeks before the expected date. 20% of these extremely preterm children shows a cerebral hemorrhage at birth, leading to a significantly i...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004160-58 Sponsor Protocol Number: CHASAP Start Date*: 2021-06-11
    Sponsor Name:Centre hospitalier intercommunal de Créteil
    Full Title: Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a multicenter prospective randomized double-blind placebo-controlled trial
    Medical condition: Pregnant women with chronic hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10036557 Pregnancy associated hypertension HLT
    20.0 100000004866 10010164 Hypertension complications HLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021576-28 Sponsor Protocol Number: DFG Fr 1455/6-1 Start Date*: 2011-06-21
    Sponsor Name:Universitätsklinikum Tuebingen
    Full Title: Effects of transfusion thresholds on neurocognitive outcome of extremely low birth weight infants (ETTNO) a blinded randomized controlled multicenter trial
    Medical condition: extreme prematurity anemia of prematurity neurodevelopmental impairment
    Disease: Version SOC Term Classification Code Term Level
    12.1 10002307 Anemia of prematurity LLT
    12.1 10036615 Prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002547-15 Sponsor Protocol Number: UTM/2012 Start Date*: 2012-11-13
    Sponsor Name:Instituto de Investigacion Sanitaria La Fe
    Full Title: UTILITY OF THE ocolytict MAINTENANCE TREATMENT IN THE MANAGEMENT OF THE THREAT OF PREMATURE
    Medical condition: Threat Preterm labor
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-005717-36 Sponsor Protocol Number: 1645-CI-057 Start Date*: 2012-06-14
    Sponsor Name:Instituto de Investigación Sanitaria La Fe
    Full Title: Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.
    Medical condition: Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002259-24 Sponsor Protocol Number: KF5503-73 Start Date*: 2015-03-16
    Sponsor Name:Grünenthal GmbH
    Full Title: Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of intravenous tapentadol solution for injection for the treatment of post-surgical pain in child...
    Medical condition: Severe post-operative pain
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004863 10036286 Post-operative pain LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) PL (Completed) GB (Completed) ES (Completed) CZ (Completed) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000953-38 Sponsor Protocol Number: MK-1986-014 Start Date*: 2018-02-07
    Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
    Medical condition: Treatment or prophylaxis against Gram-positive infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) GB (GB - no longer in EU/EEA) NO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003402-29 Sponsor Protocol Number: vitA Start Date*: 2005-10-21
    Sponsor Name:Greater Glasgow NHS Board, Yorkhill Division
    Full Title: Does additional vitamin A supplementation improve retinal function and conjunctival health in very low birth weight infants?
    Medical condition: Presumed vitamin A deficiency in preterm infants
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003099-39 Sponsor Protocol Number: LWH0604 Start Date*: 2008-08-21
    Sponsor Name:Liverpool Women's NHS Foundation Trust Hospital
    Full Title: A Randomised Controlled Trial of Thyroxine in Preterm Infants Under 28 weeks' Gestation.
    Medical condition: Hypothyroidism is a condition where there is a lack of thyroid hormone in the body. Thyroid hormones are important for normal brain development and growth. Children who are born with low thyroid ho...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018771-23 Sponsor Protocol Number: 2010-0128771-23 Start Date*: 2010-03-03
    Sponsor Name:AZIENDA OSPEDALIERA "S. CROCE E CARLE"
    Full Title: Therapy of patency of ductus arteriosus (PDA) in very low birth weight (VLBW)preterm infants: oral ibuprofen versus intravenous ibuprofen
    Medical condition: treatment on pharmacological closure of patent ductus arteriosus (PDA)in preterm very low birthweight infants.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028920 HLGT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002976-41 Sponsor Protocol Number: ZonMW522004008 Start Date*: 2019-07-09
    Sponsor Name:RIVM
    Full Title: ‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?’
    Medical condition: women in their first trimester of pregnancy
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001974-14 Sponsor Protocol Number: CCD-050000-01 Start Date*: 2023-08-11
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant a...
    Medical condition: Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2011-003473-29 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: 2022-003124-41 Sponsor Protocol Number: 219510 Start Date*: 2023-03-27
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 3b, non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV ...
    Medical condition: Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070538 Gestational hypertension PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    25.0 10036585 - Pregnancy, puerperium and perinatal conditions 10086971 Pre-eclampsia with severe features LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070532 Fetal growth restriction LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10075863 Preterm labor LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10018210 Gestational diabetes mellitus LLT
    20.0 100000004862 10008755 Chorioamnionitis LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067508 Low birth weight baby PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067509 Very low birth weight baby LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10074164 Extremely low birth weight baby LLT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    25.0 10042613 - Surgical and medical procedures 10086969 Medically induced preterm birth PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed) BE (Completed) DE (Completed) FR (Ongoing) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002624-28 Sponsor Protocol Number: FIT-EU-04 Start Date*: 2015-09-24
    Sponsor Name:Nutrinia Ltd.
    Full Title: A Multi-center, Double-blind, Randomized Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Gastrointestinal Maturation in Preterm Infants.
    Medical condition: Gastrointestinal Maturation in Preterm Infants.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) NL (Prematurely Ended) GB (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) BG (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    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: 2012-000298-22 Sponsor Protocol Number: PRENECAL Start Date*: 2012-12-05
    Sponsor Name:Fundació Clínic per a la Recerca Biomèdica
    Full Title: Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial. St...
    Medical condition: incidence of nephrocalcinosis in extremely preterm infants
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10029146 Nephrocalcinosis PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    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)
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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
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