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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 2 of 8.
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    EudraCT Number: 2013-002561-19 Sponsor Protocol Number: 1 Start Date*: 2014-03-06
    Sponsor Name:Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin
    Full Title: A prospective, double blind, randomised, placebo controlled trial to evaluate the effect of a long term tokolysis with atosiban on the pregnancy outcome. A pilot study.
    Medical condition: Premature uterine contractions premature labor
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004868 10068718 Premature uterine contractions LLT
    16.1 100000004868 10036599 Premature labor LLT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001486-90 Sponsor Protocol Number: P150944 Start Date*: 2016-06-24
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority ...
    Medical condition: Very preterm birth
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10053593 Premature baby 26 to 32 weeks LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004228-70 Sponsor Protocol Number: IBP-9414-010 Start Date*: 2015-12-28
    Sponsor Name:Infant Bacterial Therapeutics AB
    Full Title: A randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants
    Medical condition: Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-007950-77 Sponsor Protocol Number: OPPTIMUM Start Date*: 2008-07-02
    Sponsor Name:University of Edinburgh and NHS Lothian Health Board
    Full Title: Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM)
    Medical condition: Preterm labour
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003326-41 Sponsor Protocol Number: 200719 Start Date*: 2016-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-002824-13 Sponsor Protocol Number: UNI-KOELN-905 Start Date*: 2008-10-10
    Sponsor Name:University of Cologne
    Full Title: Prospective, placebo-controlled blinded clinical trial to study the efficacy of orally administered Glucose 20% for relieving pain during nasopharyngeal suctioning in preterm infants > 1500g under...
    Medical condition: Nasopharyngeal suctioning is a painful procedure that often becomes nessecary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-005495-19 Sponsor Protocol Number: pro.LISA_01_21 Start Date*: 2022-01-19
    Sponsor Name:University Hospital Schleswig-Holstein
    Full Title: A randomized controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (PRO-LISA)
    Medical condition: Respiratory distress syndrome of premature infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003466-39 Sponsor Protocol Number: Protocol_MAMA_studie_22/05/2018 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Antwerp
    Full Title: Pertussis immunization during pregnancy: assessment of the role of maternal antibodies on immune responses in term and preterm infants (the MAMA study)
    Medical condition: The effect of pertussis vaccination during pregnancy on the immune response after infant and childhood vaccinations in term and preterm infants.
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000302-31 Sponsor Protocol Number: 04/S0101/65 Start Date*: 2005-04-25
    Sponsor Name:NHS Lanarkshire, Primary Care Operating Division
    Full Title: TOLERANCE OF MILK FEEDS IN PRETERM, VERY LOW BIRTH WEIGHT BABIES: THE USE OF GLYCERINE SUPPOSITORIES
    Medical condition: The problem is inability to sustain enteral feeding in very low birth weight babies due to feed intolerance. The necessity for parenteral feeding creates risk of sepsis, cholestasis,increased oxyge...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003217-28 Sponsor Protocol Number: 14-OBE001-016 Start Date*: 2015-01-22
    Sponsor Name:ObsEva SA
    Full Title: A phase 2, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the safety and efficacy of OBE001 after oral administration in pregnant women with threaten...
    Medical condition: Treatment of preterm labour
    Disease: Version SOC Term Classification Code Term Level
    17.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036585 Pregnancy, puerperium and perinatal conditions SOC
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) DE (Completed) BE (Completed) PL (Completed) GB (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001820-39 Sponsor Protocol Number: 1984 Start Date*: 2012-12-14
    Sponsor Name:Academic medical centre
    Full Title: Levothyroxine for euthyroid women with recurrent miscarriage and thyroid autoimmunity : a randomized controlled trial
    Medical condition: Thyroid autoimmunity is associated with recurrent miscarriage and preterm birth. Thyroid autoimmunity means there is a normal thyroid function, but presence of thyroid antibodies, thyroid peroxidas...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004720-38 Sponsor Protocol Number: LATE-REC-SURF Start Date*: 2020-12-21
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Effects of late surfactant treatment delivered after a recruitment maneuver on respiratory outcomes in extremely low gestational age newborns: a randomized controlled trial – LATE-REC-SURF Trial.
    Medical condition: Preterm infants still requiring mechanical ventilation at 7-10 days of life.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10076729 Very preterm infant LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-003325-10 Sponsor Protocol Number: 1.01 Start Date*: 2012-08-10
    Sponsor Name:VU University Medical Center
    Full Title: A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth
    Medical condition: congenital anomalies
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10004953 Birth premature LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10007607 Cardiac septal defects congenital HLT
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000105-53 Sponsor Protocol Number: 17P-FU-004 Start Date*: 2011-04-20
    Sponsor Name:Hologic, Inc.
    Full Title: Estudio prospectivo, de seguimiento, de niños de 23 a 25 meses, nacidos de madres que recibieron Caproato de Hidroxiprogesterona inyectable, 250 mg/ml o vehículo, para la prevención del parto prema...
    Medical condition: Este es un estudio prospectivo, de seguimiento, diseñado para aportar una evaluación del desarrollo de niños nacidos de madres que participaron en el ensayo de eficacia de 17P
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017441-63 Sponsor Protocol Number: PRGT-PPT Start Date*: 2010-06-30
    Sponsor Name:U.O. Ginecologia e Ostetricia
    Full Title: EVALUATION OF PROGESTERONE-RELATED COMPOUNDS FOR THE TERZIARY PROPHILAXYS OF PRETERM DELIVERY: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL
    Medical condition: THREATENED PRETERM DELIVERY
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036585 SOC
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002124-24 Sponsor Protocol Number: ROPROP Start Date*: 2017-12-22
    Sponsor Name:Universität Zürich
    Full Title: Oral Propranolol for prevention of threshold retinopathy of prematurity
    Medical condition: Retinopathy of prematurity
    Disease:
    Population Age: Preterm newborn infants, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2022-002480-30 Sponsor Protocol Number: - Start Date*: 2023-07-18
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial
    Medical condition: 1400 Women with PROM at term and a GBS negative swab
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000499-24 Sponsor Protocol Number: 200722 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
    Medical condition: preterm labour and improve neonatal health
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) ES (Completed) SE (Completed) DE (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2012-004260-22 Sponsor Protocol Number: ELFIN01 Start Date*: 2013-08-28
    Sponsor Name:University of Oxford
    Full Title: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants.
    Medical condition: Late onset invasive infection in very preterm infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004297-26 Sponsor Protocol Number: C19-29 Start Date*: 2020-04-17
    Sponsor Name:Institut National de la Santé et de la Recherche Médicale (INSERM)
    Full Title: Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
    Medical condition: Patent ductus arteriosus
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) EE (Completed) IE (Completed) FI (Completed) BE (Completed) PT (Completed) SE (Completed) HU (Completed) DK (Completed) GB (Not Authorised) NO (Completed) AT (Completed) GR (Completed) PL (Ongoing) IT (Completed)
    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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