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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 7 of 8.
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    EudraCT Number: 2004-004314-16 Sponsor Protocol Number: 1 R01 NS45109-01A1 Start Date*: 2005-04-25
    Sponsor Name:NINDS
    Full Title: Ensayo multicéntrico de tratamiento de la hipotiroxinemia transitoria en los niños <= 1000 gr de peso al nacimiento o <= 28 semanas de gestación y seguimiento del desarrollo psicomotor hasta los 5 ...
    Medical condition: The aims of the study are to compare two dosing levels and the mode of administration of thyroid hormones or iodine supplementation in premature infants to achieve optimal plasma hormone targets. T...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000043-74 Sponsor Protocol Number: PNAS0122 Start Date*: 2023-07-27
    Sponsor Name:Medical University of Vienna
    Full Title: Defining and predicting neonatal inadaptation after gestational exposure to antidepressants: longitudinal exploratory analysis of psychoneuroendocrine risk factors and complications
    Medical condition: major depressive disorder poor neonatal adaptation syndrome (after antidepressant use during pregnancy)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001986-10 Sponsor Protocol Number: P150942 Start Date*: 2017-12-04
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial
    Medical condition: Pregnant women with Gestational Diabetes Mellitus (GDM)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10036585 - Pregnancy, puerperium and perinatal conditions 10018209 Gestational diabetes PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005811-34 Sponsor Protocol Number: 24d005 Start Date*: 2018-07-05
    Sponsor Name:VU Medical Center, Amsterdam
    Full Title: Pregnancy reLated Acute hyperTension INtervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial)
    Medical condition: To asses optimal treatment of hypertension of hypertensive disorders in pregnancy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004048-36 Sponsor Protocol Number: CRFB002H2301E1 Start Date*: 2016-04-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: RAINBOW extension study: an extension study to evaluate the long term efficacy and safety of RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy o...
    Medical condition: Retinopathy of Prematurity (ROP)
    Disease: Version SOC Term Classification Code Term Level
    18.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) EE (Completed) GB (GB - no longer in EU/EEA) SK (Completed) IT (Completed) BE (Completed) LT (Completed) CZ (Completed) DE (Completed) AT (Completed) SE (Completed) GR (Completed) DK (Completed) FR (Completed) HR (Completed) PL (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 (Trial now transitioned) SE (Prematurely Ended) FR (Completed) DE (Trial now transitioned) PT (Trial now transitioned) ES (Temporarily Halted) FI (Trial now transitioned) NL (Trial now transitioned) PL (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003341-15 Sponsor Protocol Number: FFIS/2019/01/AS Start Date*: 2022-10-21
    Sponsor Name:Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)
    Full Title: Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial.
    Medical condition: Pre-eclampsia
    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 (Ongoing) AT (Ongoing) DK (Trial now transitioned) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000453-41 Sponsor Protocol Number: BMBF-Fz01KG1602 Start Date*: 2018-05-29
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety...
    Medical condition: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    20.1 10017947 - Gastrointestinal disorders 10055667 Necrotising enterocolitis neonatal PT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071101 Primary apnoea of premature newborns LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002544-40 Sponsor Protocol Number: 5866 Start Date*: 2014-10-29
    Sponsor Name:Hôpitaux Universitaires de Strasbourg
    Full Title: THE TREATMENT OF HYPERTENSION ASSOCIATED WITH SEVERE PREECLAMPSIA. A RANDOMIZED CONTROLLED TRIAL OF URAPIDIL VERSUS NICARDIPINE. The URANIC trial.
    Medical condition: Hypertension associated with severe pre eclampsia
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-000622-22 Sponsor Protocol Number: ASAP Start Date*: 2012-07-20
    Sponsor Name:Fundació Clínic per a la Recerca Biomèdica
    Full Title: Aspirin for the enhancement of trophoblastic invasion in women with abnormal uterine artery Doppler at 11-14 weeks of gestation
    Medical condition: Placental insufficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10035138 Placental insufficiency PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003884-20 Sponsor Protocol Number: MK-1986-018 Start Date*: 2017-06-05
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects 3 Months to <12 Years of Age with A...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA DE (Completed) PL (Completed) BG (Completed) LT (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2007-007872-40 Sponsor Protocol Number: ROPP-2008-01 Start Date*: 2014-08-19
    Sponsor Name:Premacure AB, A member of the Shire Group of Companies
    Full Title: Determination of the rhIGF-I/rhIGFBP-3 Dose; Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-I Levels within Physiological Levels in Premature Infan...
    Medical condition: Retinopathy of Prematurity (ROP)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10015919 - Eye disorders 10015919 Eye disorders SOC
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) IT (Completed) NL (Prematurely Ended) PL (Completed)
    Trial results: View results
    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: 2022-001045-21 Sponsor Protocol Number: FSD-MIC-2022-03 Start Date*: 2023-04-10
    Sponsor Name:FUNDACION SANTIAGO DEXEUS FONT
    Full Title: A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.
    Medical condition: Infertility
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004692-40 Sponsor Protocol Number: PPL20 Start Date*: 2021-03-30
    Sponsor Name:Dilafor AB
    Full Title: An Exploratory, Open label, Randomized, Parallel-Group, Pilot Study to evaluate Safety, Tolerability and Efficacy of daily, subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4...
    Medical condition: Preeclampsia diagnosed at week 26-32 of gestation.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10040444 Severe pre-eclampsia LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001401-16 Sponsor Protocol Number: 80-83600-98-40001 Start Date*: Information not available in EudraCT
    Sponsor Name:Academic Medical Center
    Full Title: The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy
    Medical condition: The medical condition to be investigated in this trial is gestational diabetes with insufficient glycemic control by means of dietary adjustments and thus an indication for addiotional pharmacologi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10018209 Gestational diabetes PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003825-31 Sponsor Protocol Number: GDX-44-015 Start Date*: 2022-02-28
    Sponsor Name:Guerbet
    Full Title: Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI P/0145/2019
    Medical condition: Known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging) that need to be investigated by contrast-enhanced MRI of any body regio...
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004848 10029815 Nuclear magnetic resonance imaging LLT
    22.1 100000004848 10058644 Nuclear magnetic resonance imaging whole body LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017434-45 Sponsor Protocol Number: 64,185-202 Start Date*: Information not available in EudraCT
    Sponsor Name:InfaCare Pharmaceutical Corporation
    Full Title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with Hyperbilirubinemia
    Medical condition: Neonatal hyperbilirubinemia Hiperbilirubinemia neonatal
    Disease: Version SOC Term Classification Code Term Level
    14.0 10019805 - Hepatobiliary disorders 10020580 Hyperbilirubinaemia neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) ES (Prematurely Ended)
    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: 2014-001119-38 Sponsor Protocol Number: 116945 Start Date*: 2015-09-21
    Sponsor Name:GlaxoSmithKline
    Full Title: A Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix? in pregnant women.
    Medical condition: Booster immunisation against diphtheria, tetanus and pertussis diseases. The study population for this study will include pregnant women.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10047976 Whooping cough due to bordetella pertussis (B. pertussis) LLT
    18.0 100000004862 10009663 Clostridium tetani infection LLT
    18.0 100000004862 10054237 Corynebacterium diphtheriae infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) CZ (Completed) FI (Completed) IT (Completed)
    Trial results: View results
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