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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 6 of 8.
    « Previous 1  2  3  4  5  6  7  8  Next»
    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: 2006-006440-55 Sponsor Protocol Number: Amino Acid 01/2007 Start Date*: 2007-08-27
    Sponsor Name:University Childrin's Hospital
    Full Title: Effect on metabolic acidosis due to hyperammonemia of high versus low intake of amino acid in VLBW infants.
    Medical condition: At birth, a VLBW infant is abruptly disconnected from the ideal source of parenteral nutrition - the placenta. If the goal of post-natal nutrition in the VLBW infant is to mimic in utero nutrition....
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063258 Amino acid level LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001324-31 Sponsor Protocol Number: 16/2008/O/Sper Start Date*: 2008-07-09
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: Efficacy and security of oral supplementation with a probiotic (Lactobacillus reuteri) in newborns with birth weight < 1500 g: effects on necrotising enterocolitis (NEC) and gut colonization with g...
    Medical condition: necrotising enterocolitis (NEC
    Disease: Version SOC Term Classification Code Term Level
    9.1 10014878 Enteritis necroticans LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001764-29 Sponsor Protocol Number: VGFTe-ROP-1920 Start Date*: 2020-12-01
    Sponsor Name:Regeneron Pharmaceuticals. Inc.
    Full Title: Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients with Retinopathy of Prematurity
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) CZ (Completed) BG (Completed) BE (Completed) PT (Completed) GR (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-004011-44 Sponsor Protocol Number: UofATURRIFIC Start Date*: 2020-05-20
    Sponsor Name:The University of Adelaide
    Full Title: A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruri...
    Medical condition: Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) GB (GB - no longer in EU/EEA) SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005513-18 Sponsor Protocol Number: FARM6NJ3TZ Start Date*: 2007-10-04
    Sponsor Name:OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
    Full Title: Double blind randomized controlled study on the benefit-risk profile of in the treatment of at term or late preterm newborn infants with severe respiratory disorders and pulmonary hypertension
    Medical condition: treatment of at term or late preterm newborn infants with severe respiratory disorders and pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    10037400 PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000770-29 Sponsor Protocol Number: Ireland-RctV8 Start Date*: 2018-06-18
    Sponsor Name:The Rotunda Hospital
    Full Title: Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diab...
    Medical condition: Pregestational type I or type II diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045228 Type I diabetes mellitus LLT
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004880-36 Sponsor Protocol Number: CRB Start Date*: 2013-06-17
    Sponsor Name:Medizinische Universität Graz, Klinische Abteilung für Geburtshilfe, Univ. Klinik für Frauenheilkunde und Geburtshilfe
    Full Title: Efficacy of induction of labor on term using a double balloon catheter compared to Dinoprostone vaginal-insert – a multicenter randomized controlled trial.
    Medical condition: Gestational age between the 37th and 42th gestation week
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002622-79 Sponsor Protocol Number: IMIB-GU-2019-02 Start Date*: 2020-06-17
    Sponsor Name:Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
    Full Title: Gestational treatment with Ursodeoxycholic Acid compared to Placebo to Reduce Severity of Gestational Diabetes Mellitus diagnosed at 24-28 weeks’ gestation
    Medical condition: Gestational Diabetes Mellitus
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000811-26 Sponsor Protocol Number: STOPPRE Start Date*: 2018-09-19
    Sponsor Name:Vall D'Hebron Institut de Recerca (VHIR)
    Full Title: A phase III, multicentric, Randomized, open-label, parallel-group clinical trial to detect false positives from first-trimester preeclampsia screening (StopPRE) at the second-trimester of pregnancy.
    Medical condition: First-trimester pre-eclampsia patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002385-31 Sponsor Protocol Number: 2015/582 Start Date*: 2017-08-28
    Sponsor Name:Professor Peter Humaidan, The Fertility Clinic Skive
    Full Title: A double-blind, placebo-controlled multicenter trial on the effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota
    Medical condition: Infertility
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10021572 In vitro fertilization LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    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: 2011-000310-19 Sponsor Protocol Number: 2011-000310-19 Start Date*: 2011-08-09
    Sponsor Name:Lund University
    Full Title: Fentanyl treatment in newborn infants: A Pharmacokinetic, Pharmacodynamic, and Pharmacogenetic Study (PK/PD model)
    Medical condition: Neonatal Pain
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005005-28 Sponsor Protocol Number: ADENOFERT Start Date*: 2022-11-08
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: Assisted reproductive technology (ART) and pregnancy outcomes in women with adenomyosis (internal endometriosis) according to stimulation protocol in relation to immunological and endometrial featu...
    Medical condition: Women with transvaginal ultrasound (TV-US)-based diagnosis of adenomyosis and women without adenomyosis but with similar baseline reproductive risks
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038604 - Reproductive system and breast disorders 10014778 Endometriosis PT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Trial now transitioned)
    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: 2021-000994-96 Sponsor Protocol Number: 214725 Start Date*: 2021-07-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase III, double-blind, randomized, placebo-controlled study to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of unadjuvanted RSV Maternal vaccine, in hi...
    Medical condition: High risk pregnant women (prevention of RSV-associated lower respiratory tract illnesses (LRTIs) in infants)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed) ES (Temporarily Halted) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005979-16 Sponsor Protocol Number: PrOvAS001 Start Date*: 2013-04-29
    Sponsor Name:Instituto de Investigación Sanitaria La Fe
    Full Title: PREECLAMPSIA OF PREVENTION IN PATIENTS THROUGH ovodonation aspirin in early gestation
    Medical condition: PREECLAMPSIA
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000315-76 Sponsor Protocol Number: 1375_RCF_MAC Start Date*: 2021-12-06
    Sponsor Name:Centro Hospitalar Universitário de Lisboa Central, EPE
    Full Title: Low molecular weight heparin in the treatment of early fetal growth restriction
    Medical condition: Early 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: PT (Trial now transitioned)
    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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