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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 4 of 8.
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    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 (Completed) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003041-10 Sponsor Protocol Number: CRFB002H2301 Start Date*: 2015-04-14
    Sponsor Name:NOVARTIS FARMA S.p.A.
    Full Title: RAINBOW study: a randomized, controlled study evaluating the efficacy and safety of RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy of prematu...
    Medical condition: Retinopathy of prematurity (ROP)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) EE (Completed) LT (Completed) HU (Completed) BE (Completed) AT (Completed) DE (Completed) GB (Completed) HR (Completed) FR (Completed) SK (Completed) CZ (Completed) GR (Completed) DK (Completed) FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-004955-19 Sponsor Protocol Number: PARIDA-01/2013 Start Date*: 2014-09-03
    Sponsor Name:Azienda Ospedaliera di Padova
    Full Title: PARACETAMOL VERSUS IBUPROFEN FOR PATENT DUCTUS ARTERIOSUS TREATMENT IN PRETERM INFANTS.
    Medical condition: patent ductus arteriosus hemodynamically important
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10034190 PDA Repair patent ductus arteriosus LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    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: 2020-005552-38 Sponsor Protocol Number: ProFET Start Date*: 2021-01-27
    Sponsor Name:Västragötalandsregionen, Sahlgrenska Universitetssjukhuset
    Full Title: Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial
    Medical condition: infertility
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Trial now transitioned) IS (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-002203-15 Sponsor Protocol Number: PregMet2 Start Date*: 2012-08-08
    Sponsor Name:NTNU, Norwegian University of Science and Technology
    Full Title: Metformin treatment of pregnant PCOS women and prevention of late miscarriages and preterm birth The PregMet 2 Study
    Medical condition: Poly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias: - at least 2 out of 3 criterias 1.PCO in at least one ovary 2.Olig...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10065161 Polycystic ovarian syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: NO (Completed) SE (Completed) IS (Completed)
    Trial results: View results
    EudraCT Number: 2015-001714-96 Sponsor Protocol Number: R2222-RSV-1332 Start Date*: 2015-11-03
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in ...
    Medical condition: Medically attended respiratory syncytial virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10038717 Respiratory syncytial viral infections HLT
    Population Age: Preterm newborn infants, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) GB (Completed) HU (Completed) FI (Completed) BG (Completed) ES (Completed) CZ (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000241-13 Sponsor Protocol Number: PESAPRO Start Date*: 2012-04-13
    Sponsor Name:Dra. Martinez Payo-Hospital Universitario Puerta de Hierro
    Full Title: Prevention of preterm birth in women at risk identified by ultrasound: evaluation of two treatment strategies.
    Medical condition:
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-005752-10 Sponsor Protocol Number: AT-100/001 Start Date*: 2023-04-20
    Sponsor Name:Airway Therapeutics, Inc.
    Full Title: A Phase 1b, Randomized, Blinded, Dose-Determined Study Evaluating the Safety and Tolerability Profile of Intervention with AT-100 (rhSP-D) in Preterm Neonates at High Risk for the Development of Br...
    Medical condition: Bronchopulmonary Dysplasia (BPD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003410-12 Sponsor Protocol Number: RG_19-169 Start Date*: 2020-12-16
    Sponsor Name:University of Birmingham
    Full Title: Pregnancy ANtihypertensive Drugs: which Agent is best?
    Medical condition: Hypertension in pregnancy (chronic hypertension, gestational hypertension or pre-eclampsia)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-003666-41 Sponsor Protocol Number: MEC2020-0078 Start Date*: 2020-04-21
    Sponsor Name:Erasmus MC University Medical Center
    Full Title: Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial.
    Medical condition: Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Co...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077323 Infantile mixed apnea LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001137-41 Sponsor Protocol Number: 666 Start Date*: 2018-06-26
    Sponsor Name:Hvidovre Hospital. Dep of Respiratory Medicine
    Full Title: Use of Omalizumab will increase the pregnancy rate, proof of concept study, where women with asthma and infertility will be treated three times with weight and IgE balanced dosis at the sixth day o...
    Medical condition: infertility within female asthma patients as a result of systemic inflamation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004740-36 Sponsor Protocol Number: MINT (CRO1834) Start Date*: 2011-08-04
    Sponsor Name:Imperial College, London
    Full Title: Melatonin As A Novel Neuroprotectant In Preterm Infants−Trial Study
    Medical condition: Brain injury from prematurity
    Disease: Version SOC Term Classification Code Term Level
    14.0 10036585 - Pregnancy, puerperium and perinatal conditions 10013384 Disorders relating to short gestation and unspecified low birthweight LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003778-29 Sponsor Protocol Number: CTU/2013/064 Start Date*: 2014-01-30
    Sponsor Name:University College London
    Full Title: Combined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-based Pre-eclampsia Prevention
    Medical condition: Pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    18.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed) IT (Completed) BE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-020464-38 Sponsor Protocol Number: PRENU Start Date*: 2010-06-08
    Sponsor Name:University of Oslo
    Full Title: Nutrition, growth and development among very preterm infants
    Medical condition: The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids DHA and AA to Very Low Birth Weight Infants...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004491-17 Sponsor Protocol Number: REMODEL Start Date*: 2021-03-31
    Sponsor Name:UZ Brussel
    Full Title: Dydrogesterone versus micronized vaginal progesterone (MVP) for luteal phase support (LPS) in hormone replacement therapy (HRT) frozen embryo transfer (FET) cycles.
    Medical condition: progesterone as luteal phase supplementation in frozen embryo transfer cycles
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004680-31 Sponsor Protocol Number: 2018-004680-31 Start Date*: 2019-08-16
    Sponsor Name:Lene Ringholm
    Full Title: A randomised controlled trial comparing the effect of the faster-acting insulin analog - insulin Fiasp® – versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during p...
    Medical condition: Type 1 and type 2 diabetes during pregnancy and lactation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10012614 Diabetes mellitus NOS LLT
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-023777-19 Sponsor Protocol Number: SToP-BPD Start Date*: Information not available in EudraCT
    Sponsor Name:Academic Medical Center
    Full Title: Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants: the SToP-BPD study
    Medical condition: bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10006475 Bronchopulmonary dysplasia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: (No results available)
    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: 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
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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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