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Clinical trials for Pre-term 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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    18 result(s) found for: Pre-term birth. Displaying page 1 of 1.
    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
    EudraCT Number: 2007-007550-66 Sponsor Protocol Number: Emulipid Start Date*: 2008-02-21
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Lipidic emulsions influence on immune response of pre-term VLBW newborns treated with total parenteral nutrition
    Medical condition: very low birth weight newborn
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036590 Premature baby LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-002800-16 Sponsor Protocol Number: C3591024 Start Date*: 2019-12-10
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANT...
    Medical condition: Infections with suspected or confirmed Gram-negative pathogens
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10032531 Other specified bacterial infections in conditions classified elsewhere and of unspecified site LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) EE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001707-38 Sponsor Protocol Number: PN-0709 Start Date*: 2007-07-31
    Sponsor Name:University Hospital
    Full Title: A phase IIIb, open, controlled study to evaluate the immunogenicity, and safety of 7PCV Prevenar vaccine in pre-term infants
    Medical condition: Premature children suffer from large variety of different accompanying diseases. Pneumoccocal diseases creates substantial proportion especially in children with undergoing diseases of respiratory ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054047 Pneumococcal sepsis LLT
    9.1 10027253 Meningitis pneumococcal LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002405-26 Sponsor Protocol Number: MK-1654-004 Start Date*: 2021-01-14
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
    Medical condition: Prevention of RSV
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    21.1 10042613 - Surgical and medical procedures 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA FI (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005996-11 Sponsor Protocol Number: MK-1654-007 Start Date*: 2021-08-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for S...
    Medical condition: Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned) Outside EU/EEA HU (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    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: 2013-005336-23 Sponsor Protocol Number: Baby-OSCAR Start Date*: 2014-12-16
    Sponsor Name:University of Oxford
    Full Title: Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies
    Medical condition: Patent ductus arteriosus of the newborn
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-000456-15 Sponsor Protocol Number: 3518 Start Date*: 2015-05-19
    Sponsor Name:Kings College London [...]
    1. Kings College London
    2. Guys and St Thomas' NHS Foundation Trust
    Full Title: The prevention of pre-term birth in women who develop a short cervix. A multi-centre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal proges...
    Medical condition: Short Cervix in Pregnancy
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004868 10021632 Incompetent cervix LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-000048-17 Sponsor Protocol Number: NN1250-4300 Start Date*: 2017-10-12
    Sponsor Name:Novo Nordisk A/S
    Full Title: A trial comparing the effect and safety of insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes.
    Medical condition: Diabetes Mellitus, Type 1
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed) GB (GB - no longer in EU/EEA) AT (Completed) IE (Completed) GR (Completed) ES (Prematurely Ended) HR (Completed) IT (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: 2013-003889-14 Sponsor Protocol Number: C12-75 Start Date*: 2014-12-09
    Sponsor Name:Institut National de la Santé et de la Research Médicale
    Full Title: A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants
    Medical condition: Bronchopulmonary Dysplasia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10066204 Chronic lung disease of prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) DE (Ongoing) NL (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-004890-29 Sponsor Protocol Number: FIT-PIV Start Date*: 2023-03-09
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005281-30 Sponsor Protocol Number: DUR001-306 Start Date*: 2016-11-03
    Sponsor Name:Allergan Ltd.
    Full Title: A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Sk...
    Medical condition: Acute bacterial skin and skin structure infection. For Cohort 5 (from birth to less than 3 months) also patients with sepsis are allowed.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10066412 Staphylococcus aureus skin infection LLT
    20.0 10021881 - Infections and infestations 10037633 Pyoderma (skin infection) LLT
    20.1 10021881 - Infections and infestations 10040873 Skin infection aggravated LLT
    20.0 10021881 - Infections and infestations 10040872 Skin infection PT
    20.0 10021881 - Infections and infestations 10040875 Skin infection pyogenic LLT
    20.0 10021881 - Infections and infestations 10040874 Skin infection NOS LLT
    20.1 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    20.0 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) LT (Prematurely Ended) ES (Prematurely Ended) BG (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002606-20 Sponsor Protocol Number: CV185-325/B0661037 Start Date*: 2015-11-06
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
    Medical condition: Venous Thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004866 10043565 Thromboembolic event LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) Outside EU/EEA AT (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) PT (Completed) IT (Not Authorised) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2004-000199-14 Sponsor Protocol Number: N01009 Start Date*: 2004-11-25
    Sponsor Name:UCB Pharma S.A. [...]
    1. UCB Pharma S.A.
    2. UCB Pharma Inc.
    Full Title: A double-blind, randomized, multicenter, placebo-controlled, in-patients maximum 34 day study of levetiracetam oral solution (20-50 mg/kg/day) as adjunctive treatment of refractory partial onset se...
    Medical condition: Epilepsy - Refractory Partial Onset Seizures
    Disease: Version SOC Term Classification Code Term Level
    7.0 10061334 LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) BE (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004318-16 Sponsor Protocol Number: DAS181-3-01 Start Date*: 2020-01-16
    Sponsor Name:Ansun Biopharma, Inc.
    Full Title: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
    Medical condition: Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10033796 Parainfluenzae viral infections HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DK (Prematurely Ended) FR (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-004195-42 Sponsor Protocol Number: FIT-05 Start Date*: 2023-04-13
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SE (Ongoing) ES (Ongoing) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
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