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Clinical trials for Neonatal and perinatal conditions

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    38 result(s) found for: Neonatal and perinatal conditions. Displaying page 1 of 2.
    1  2  Next»
    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: 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: 2011-000174-66 Sponsor Protocol Number: APOSTELIV Start Date*: 2012-02-07
    Sponsor Name:Academic Medical Centre
    Full Title: Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour (APOSTEL IV); Nifedipine versus placebo in the treatment of preterm premature rupture of membranes
    Medical condition: Premature preterm rupture of membranes
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002919-28 Sponsor Protocol Number: CORTLATE Start Date*: 2011-07-12
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    Full Title: Antenatal corticosteroids and respiratory distress syndrome in late preterm infants born by elective cesarean section. Multicentric randomized controlled clinical trial
    Medical condition: Prophylaxis of respiratory distress syndrome in late preterm infants (34-36 weeks of gestational age)with antenatal corticosteroids
    Disease: Version SOC Term Classification Code Term Level
    14.0 10036585 - Pregnancy, puerperium and perinatal conditions 10028920 Neonatal and perinatal conditions HLGT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Prematurely Ended)
    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: 2022-003124-41 Sponsor Protocol Number: 219510 Start Date*: 2023-03-27
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 3b, non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV ...
    Medical condition: Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070538 Gestational hypertension PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    25.0 10036585 - Pregnancy, puerperium and perinatal conditions 10086971 Pre-eclampsia with severe features LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070532 Fetal growth restriction LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10075863 Preterm labor LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10018210 Gestational diabetes mellitus LLT
    20.0 100000004862 10008755 Chorioamnionitis LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067508 Low birth weight baby PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067509 Very low birth weight baby LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10074164 Extremely low birth weight baby LLT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    25.0 10042613 - Surgical and medical procedures 10086969 Medically induced preterm birth PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed) BE (Completed) DE (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-004396-51 Sponsor Protocol Number: ZKS_0021PETN Start Date*: 2017-06-26
    Sponsor Name:Friedrich Schiller University
    Full Title: Pentaerithrityl tetranitrate (PETN) for secondary prevention of intrauterine growth restriction (PETN Trial)
    Medical condition: Pregnant women at risk of adverse pregnancy outcome due to intrauterine growth retardation identified by impaired uterine Doppler measurements at mid gestation (19+0 - 22+6 weeks of gestation).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070531 Foetal growth restriction PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    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: 2011-002095-17 Sponsor Protocol Number: MAGSPET Start Date*: 2011-09-13
    Sponsor Name:Anna Suy Franch
    Full Title: Sulfato de magnesio en pauta continua versus discontinua en la conducta expectante de la preeclampsia grave: ensayo clínico aleatorizado
    Medical condition: Preeclampsia grave
    Disease: Version SOC Term Classification Code Term Level
    14.0 10036585 - Pregnancy, puerperium and perinatal conditions 10040445 Severe pre-eclampsia, antepartum LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-005371-15 Sponsor Protocol Number: DM/PR/5000/004/05 Start Date*: 2006-04-05
    Sponsor Name:CHIESI
    Full Title: A RANDOMIZED CONTROLLED STUDY TO EVALUATE THE EFFICACY OF A SUPPLEMENTAL DOSE OF CUROSURF IN PRE-TERM INFANTS ON MECHANICAL VENTILATION FOR RESPIRATORY DISTRESS SYNDROME RDS IN PREVENTING EXTUBAT...
    Medical condition: RDS - preterm infants
    Disease: Version SOC Term Classification Code Term Level
    6.1 10028974 PT
    Population Age: Preterm newborn infants Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000145-40 Sponsor Protocol Number: versión2.febrero2017 Start Date*: 2017-09-20
    Sponsor Name:montserrat zamora brito
    Full Title: Use of acupuncture for the reduction of hospital admissions in the induction of labor due to chronologically prolonged gestation. ACUPUNT STUDY
    Medical condition: This Clinical Trial will evaluate the efficacy and safety of acupuncture to promote labor in pregnant women who need an induction at birth and thus be able to give answers to all these women who a...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004439-22 Sponsor Protocol Number: CHUBX2018/64 Start Date*: 2020-03-12
    Sponsor Name:CHU de Bordeaux
    Full Title: TRAnexamic Acid for Preventing blood loss following a cesarean delivery in women with placenta pREVIA: a multicenter randomised, double blind placebo controlled trial (TRAAPrevia)
    Medical condition: Postpartum hemorrhage, placenta previa, prevention, blood loss, transfusion
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036417 Postpartum haemorrhage PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036585 Pregnancy, puerperium and perinatal conditions SOC
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001815-25 Sponsor Protocol Number: UCDCRC/22/01 Start Date*: 2022-12-06
    Sponsor Name:University College Dublin
    Full Title: Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)
    Medical condition: Pregnant women
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10010273 Pregnancy, labour, delivery and postpartum conditions HLGT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018771-23 Sponsor Protocol Number: 2010-0128771-23 Start Date*: 2010-03-03
    Sponsor Name:AZIENDA OSPEDALIERA "S. CROCE E CARLE"
    Full Title: Therapy of patency of ductus arteriosus (PDA) in very low birth weight (VLBW)preterm infants: oral ibuprofen versus intravenous ibuprofen
    Medical condition: treatment on pharmacological closure of patent ductus arteriosus (PDA)in preterm very low birthweight infants.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028920 HLGT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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: 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: 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: 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: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-005206-19 Sponsor Protocol Number: FFIS/2016/02/ST Start Date*: 2017-05-26
    Sponsor Name:Fundación para la Formación e Investigación Sanitaria (FFIS)
    Full Title: Randomised Controlled Trial with Pravastatin versus Placebo for Prevention of Preeclampsia
    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 (GB - no longer in EU/EEA) BE (Completed) ES (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
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