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Clinical trials for Neonate

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    68 result(s) found for: Neonate. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2009-015659-26 Sponsor Protocol Number: 2009-015659-26 Start Date*: 2010-01-22
    Sponsor Name:Karolinska Institutet
    Full Title: Cortical and hormonal stress responses to pain management with morphine in standard clinical dosage
    Medical condition: Neonatal pain
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056350 Pain management LLT
    12.1 10022519 Intensive care LLT
    12.1 10029392 Newborn LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002256-25 Sponsor Protocol Number: HYPATIA Start Date*: 2018-03-09
    Sponsor Name:Guy's and St Thomas' NHS Foundation Trust
    Full Title: HYPATIA: A prospective randomised controlled trial of HYdroxychloroquine to improve Pregnancy outcome in women with AnTIphospholipid Antibodies
    Medical condition: Pregnant women with antiphospholipid antibodies
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10048678 Antiphospholipid antibodies positive PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002648-26 Sponsor Protocol Number: S54472 Start Date*: 2013-10-16
    Sponsor Name:UZ Leuven
    Full Title: Exploratory Propofol Dose Finding Study In Neonates.
    Medical condition: Investigation of the most effective intravenously administered single propofol dose for successful INSURE prodecure and for (semi-)elective intubation of neonates in non-INSURE conditions (e.g. sur...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004869 10028977 Neonate LLT
    16.0 10042613 - Surgical and medical procedures 10067450 Endotracheal intubation PT
    16.0 10042613 - Surgical and medical procedures 10049124 Sedation during medical procedure LLT
    16.0 10022891 - Investigations 10061134 Drug level therapeutic PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004958-42 Sponsor Protocol Number: MOM-M281-003 Start Date*: 2019-01-11
    Sponsor Name:Momenta Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease ...
    Medical condition: Early onset Severe Hemolytic Disease of the fetus and newborn (HDFN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10019512 Hemolytic disease due to Rh isoimmunization of fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) NL (Ongoing) SE (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005572-17 Sponsor Protocol Number: 20132312 Start Date*: 2014-05-21
    Sponsor Name:Erasmus Medical Center
    Full Title: Optimizing propofol dosing for (preterm) newborn infants that need endotracheal intubation
    Medical condition: Sedation for endotracheal intubation in newborns of different ages at the neonatal intensive care unit
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004869 10029392 Newborn LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-005577-36 Sponsor Protocol Number: neopopgen_v1.0 Start Date*: 2015-04-02
    Sponsor Name:Teijo Saari
    Full Title: Individualising propofol and oxycodone therapy in neonates using pharmacogenomic profiling, population based modeling and simulations.
    Medical condition: Neonates, who need to be intubated and ventilated with a ventilator.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004264-19 Sponsor Protocol Number: NEODEX2 Start Date*: 2017-04-05
    Sponsor Name:Uppsala County Council
    Full Title: Anesthesia with dexmedetomidine and fentanyl for neonatal surgery. A pilot study.
    Medical condition: The state of anesthesia intraoperatively and pain postoperatively
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011208-42 Sponsor Protocol Number: HTA0830801 Start Date*: 2010-02-18
    Sponsor Name:Imperial College, London [...]
    1. Imperial College, London
    2. Academic Medical Center Amsterdam
    Full Title: First trimester progesterone therapy to reduce miscarriages in women with a history of unexplained recurrent miscarriages: A randomised, double blind, placebo-controlled, multi-centre trial [The PR...
    Medical condition: Recurrent Miscarriage
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-000719-19 Sponsor Protocol Number: 09/100/10 Start Date*: 2011-05-05
    Sponsor Name:University of Birmingham
    Full Title: A Randomised Controlled Trial of the Efficacy and Mechanism of Levothyroxine Treatment on Pregnancy and Neonatal Outcomes in Women with Thyroid Antibodies. (TABLET: Thyroid AntiBodies and LEvoThyro...
    Medical condition: Thyroid autoimmunity and history of miscarriage or infertility.
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002980-25 Sponsor Protocol Number: PRESERV Start Date*: 2020-06-12
    Sponsor Name:OSP.DEGLI INFERMI DI BIELLA
    Full Title: Randomized, multicenter, open-label study on PREvention of respiratory SEquelae of RSV bronchiolitis in preterm babies (PRESERV)
    Medical condition: Respiratory sincizial virus (RSV) bronchiolitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005330-10 Sponsor Protocol Number: 987654321 Start Date*: 2013-03-14
    Sponsor Name:Erasmus University Medical Centre
    Full Title: Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.
    Medical condition: Pregnant patients with preeclampsia (hypertension and protein/creatinine ratio ≥ 30mg/mmol or ≥ 300mg protein/24hours) complicated with severe hypertension (systolic bloodpressure ≥ 160mmHg and/or ...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004192-12 Sponsor Protocol Number: NL66079.029.18 Start Date*: 2019-08-05
    Sponsor Name:Amsterdam UMC, location VU medical Center
    Full Title: Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial
    Medical condition: The research population consists of infertile couples who have tried to conceive for at least 12 months, or have oligo- or anovulation. We will focus on women with ovulation disorders, or at high r...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004153-24 Sponsor Protocol Number: NL62838.029.18 Start Date*: 2019-07-30
    Sponsor Name:Amsterdam UMC - location Vrije Universiteit Amsterdam
    Full Title: Tubal flushing with oil-based contrast during HSG in subfertile women: Is early flushing effective and cost-effective as compared to delayed flushing?
    Medical condition: The research population consists of infertile women aged between 18 and 39 years of age, who have a spontaneous menstrual cycle and with a perceived low risk for tubal pathology, undergoing fertili...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003275-22 Sponsor Protocol Number: NEODEX1 Start Date*: 2016-12-14
    Sponsor Name:Uppsala County Council
    Full Title: Evaluation of the analgesic and sedative effects of dexmedetomidine for neonatal peripheral vein cannulation
    Medical condition: Pain on i v cannulation
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006080-23 Sponsor Protocol Number: DPMFM PC1036 Start Date*: 2007-03-21
    Sponsor Name:Institute of Obstetrics and Gynaecology Trust
    Full Title: Vitamin D status in pregnancy and the effects of vitamin D supplementation in ethnic minority groups
    Medical condition: Low vitamin D levels in pregnant women especially in ethnic minority groups
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003603-61 Sponsor Protocol Number: 002 Start Date*: 2017-07-19
    Sponsor Name:
    Full Title: Clinical trial on the administration of 3 doses of betamethasone (12 mg) in 18 hours apart in twin pregnancy patients with threatened preterm birth treated by Atosiban, rather than 2 doses of betam...
    Medical condition: Premature delivery in twin pregnancies
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004868 10028244 Multiple pregnancy affecting fetus or newborn LLT
    19.1 100000004868 10036564 Pregnancy multiple LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010759-29 Sponsor Protocol Number: 001 Start Date*: 2009-04-27
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: étude clinique sur l’administration de 3 doses de betaméthasone (12mg) à 18 heures d’intervalle lors d’une menace d’accouchement prématuré dans les grossesses gémellaires traitées par Atosiban, plu...
    Medical condition: Premature delivery in twin pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036564 Pregnancy multiple LLT
    9.1 10028244 Multiple pregnancy affecting fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-004314-16 Sponsor Protocol Number: 1 R01 NS45109-01A1 Start Date*: 2005-04-25
    Sponsor Name:NINDS
    Full Title: Ensayo multicéntrico de tratamiento de la hipotiroxinemia transitoria en los niños <= 1000 gr de peso al nacimiento o <= 28 semanas de gestación y seguimiento del desarrollo psicomotor hasta los 5 ...
    Medical condition: The aims of the study are to compare two dosing levels and the mode of administration of thyroid hormones or iodine supplementation in premature infants to achieve optimal plasma hormone targets. T...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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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