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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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    155 result(s) found for: Preterm birth. Displaying page 8 of 8.
    « Previous 1  2  3  4  5  6  7  8 
    EudraCT Number: 2021-000062-14 Sponsor Protocol Number: MN42988 Start Date*: 2021-10-08
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY
    Medical condition: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10071068 Clinically isolated syndrome PT
    Population Age: In utero, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-000284-21 Sponsor Protocol Number: 524E-CVD-9101-004 Start Date*: 2007-11-08
    Sponsor Name:York Hospitals NHS Foundation Trust [...]
    1. York Hospitals NHS Foundation Trust
    2. University of York
    Full Title: A multicentre, multinational randomised control trial of prophylactic low molecular weight heparin(LMWH) in high risk pregnant thrombophilic women
    Medical condition: Thrombophilia in pregnancy. This is a multi-centre, multi-national randomised controlled trial of Low Molecular Weight Heparin to prevent pregnancy complications in high-risk pregnant thrombophi...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10057396 Thrombophilia LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003237-25 Sponsor Protocol Number: POPPIV4.022.07.16 Start Date*: 2015-08-21
    Sponsor Name:University of Oxford
    Full Title: A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants
    Medical condition: Screening for Retinopathy of Prematurity is an essential yet painful routine test that is performed multiple times in infants who are born prematurely. Premature infants also regularly require heel...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001832-27 Sponsor Protocol Number: AT-202 Start Date*: 2023-01-20
    Sponsor Name:Allecra Therapeutics SAS
    Full Title: A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Part...
    Medical condition: Complicated urinary tract infections including acute pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10037597 Pyelonephritis acute PT
    20.0 10021881 - Infections and infestations 10046577 Urinary tract infections HLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) SK (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002756-27 Sponsor Protocol Number: N01349 Start Date*: Information not available in EudraCT
    Sponsor Name:UCB Biopharma SPRL
    Full Title: A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures
    Medical condition: Electroencephalographic neonatal seizures
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) BE (Prematurely Ended) CZ (Completed) HU (Completed) NL (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-000429-20 Sponsor Protocol Number: 05-NEOV-001 Start Date*: 2008-10-17
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study evaluating the safety, tolerability, and amino acid plasma levels of Neoven compared to Vaminolact in infants after surgical interventions.
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The indended indication is: Supply of essential and non-essential amino acids as part of parenteral nutrition for preterm an...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051284 Parenteral nutrition LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002023-11 Sponsor Protocol Number: 53718678RSV3001 Start Date*: 2021-02-16
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (...
    Medical condition: Respiratory Syncytial Virus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) DE (Prematurely Ended) SE (Completed) CZ (Completed) HU (Completed) BE (Completed) PL (Completed) Outside EU/EEA EE (Completed) LV (Completed) SK (Completed) IT (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: 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: 2012-001918-42 Sponsor Protocol Number: 2009-107(Canadian) Start Date*: 2014-01-17
    Sponsor Name:Ottawa Hospital Research Institute
    Full Title: Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT) A randomized, double-blind, placebo-controlled, Phase III, international multi-centre study of 4...
    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: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003717-18 Sponsor Protocol Number: 215226/VIR-7831-5005 Start Date*: 2021-12-30
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovim...
    Medical condition: COVID-19 at high risk of disease progression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002452-25 Sponsor Protocol Number: EP0065 Start Date*: 2018-04-11
    Sponsor Name:UCB BIOPHARMA SPRL
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF INTRAVENOUS BRIVARACETAM IN SUBJECTS ≥1 MONTH TO <16 YEARS OF AGE WITH EPILEPSY
    Medical condition: Localization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) CZ (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001411-39 Sponsor Protocol Number: ABT-002 Start Date*: 2018-09-04
    Sponsor Name:Abeona Therapeutics Inc
    Full Title: Phase I/II gene transfer clinical trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB
    Medical condition: MPS IIIB is a devastating lysosomal storage disease, caused by a N-α-acetylglucosaminidase (NAGLU) gene defect. Infants with MPS IIIB appear normal at birth, but the disease is relentlessly progre...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) FR (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-000974-22 Sponsor Protocol Number: MRX-701 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy
    Medical condition: Biliary atresia (BA) is a rare, inflammatory condition of the biliary tree that presents in the first weeks of life and leads to bile duct obstruction and consequent liver injury, fibrosis and cirr...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004165-13 Sponsor Protocol Number: IJB-LBC-NEOCHECKRAY-2018 Start Date*: 2019-06-06
    Sponsor Name:Institut Jules Bordet
    Full Title: Neo-adjuvant chemotherapy combined with SBRT to the primary tumour +/- durvalumab (MEDI4736), +/- oleclumab in luminal B breast cancer: a phase ll randomized trial
    Medical condition: Luminal B Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Trial now transitioned) 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
    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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