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Clinical trials for NICU

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   44335   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    63 result(s) found for: NICU. Displaying page 1 of 4.
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    EudraCT Number: 2016-004198-41 Sponsor Protocol Number: UCDCRC/16/003 Start Date*: 2017-01-27
    Sponsor Name:University College Dublin
    Full Title: PROPHYLACTIC OROPHARYNGEAL SURFACTANT FOR PRETERM INFANTS: A RANDOMISED TRIAL (THE POPART TRIAL)
    Medical condition: Preterm Infants at risk of respiratory distress syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10042613 - Surgical and medical procedures 10054933 Neonatal respiratory distress syndrome prophylaxis PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) BE (Completed) SE (Completed) CZ (Completed) PT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2013-004655-21 Sponsor Protocol Number: KRN-001 Start Date*: 2014-06-23
    Sponsor Name:Kern Pharma S.L.
    Full Title: New Dosing Systems in Paediatrics. Application to the individualization of the dose of fentanyl in neonatal patients.
    Medical condition: Analgesia, sedation.
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002203-15 Sponsor Protocol Number: PregMet2 Start Date*: 2012-08-08
    Sponsor Name:NTNU, Norwegian University of Science and Technology
    Full Title: Metformin treatment of pregnant PCOS women and prevention of late miscarriages and preterm birth The PregMet 2 Study
    Medical condition: Poly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias: - at least 2 out of 3 criterias 1.PCO in at least one ovary 2.Olig...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10065161 Polycystic ovarian syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: NO (Completed) SE (Completed) IS (Completed)
    Trial results: View results
    EudraCT Number: 2015-001654-15 Sponsor Protocol Number: NL53018.015.15 Start Date*: 2015-10-15
    Sponsor Name:Máxima Medisch Centrum
    Full Title: Intrauterine resuscitation during term labor by maternal hyperoxygenation.
    Medical condition: Fetal distress during the second stage of labor.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    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: 2008-007498-19 Sponsor Protocol Number: COL-1620-302 Start Date*: 2009-09-17
    Sponsor Name:Columbia Laboratories, Inc
    Full Title: The Effect of Vaginal Progesterone Administration in the prevention of Preterm Birth in Women with Short Cervix, [also Known as: Vaginal progesterone bioadhesive gel (Prochieve)® Extending Gestatio...
    Medical condition: Preterm birth (less than or equal to 32 6/7 weeks gestation)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: CZ (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 (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-000851-33 Sponsor Protocol Number: 27112001 Start Date*: 2008-04-28
    Sponsor Name:Medizinische Unversität Wien, Abteilung für Kinder- und Jugendheilkunde
    Full Title: Impact of oral application of Gastrografin on the meconium evacuation in very low birth weight infants
    Medical condition: Evacuation of inspissated meconium in very low birth weight infants (infants with a birthweight below 1500 grams)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-001269-32 Sponsor Protocol Number: 01/05 Start Date*: 2005-12-27
    Sponsor Name:Universitätskinderklinik Innsbruck
    Full Title: Clinical trial on skin care in Neonatology. A comparison between two skin care products and no skin care
    Medical condition: Normal skin care of newborns
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005180-16 Sponsor Protocol Number: FFIS/2015/02/EV Start Date*: 2016-09-08
    Sponsor Name:Fundación para la Formación e Investigación Sanitaria
    Full Title: Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial.
    Medical condition: Spontaneous preterm birth in twin pregnancies.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10023555 Labour premature LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) ES (Completed) BG (Completed) IT (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-002506-37 Sponsor Protocol Number: SANNI-project:03 Start Date*: 2020-01-08
    Sponsor Name:Region Skane
    Full Title: Dexmedetomidine for analgosedation to newborn infants during neonatal intensive care – a prospective pharmacokinetic/ pharmacodynamic/ pharmacogenetic observational study.Cohort 3 in The SANNI Pr...
    Medical condition: Sick newborn infants in need of intensive care.
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002148-15 Sponsor Protocol Number: 201500214815 Start Date*: 2017-06-01
    Sponsor Name:Bethesda Diabetes research Center (BDRC)
    Full Title: Pregnancy Outcomes: Effects of Metformin Study (POEM Study) a long term randomized controlled parallel group study in gestational diabetes mellitus
    Medical condition: Gestational diabetes mellitus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-014256-30 Sponsor Protocol Number: HU08/NEONAT/REMIFENTANIL Start Date*: 2009-09-11
    Sponsor Name:Hôpital Universitaire Des Enfants Reine Fabiola
    Full Title: Une analgésie de choix pour l'intubation des nouveau-nés : Etude multicentrique randomisée comparant le rémifentanil à l'association morphine-midazolam
    Medical condition: Preterm newborn & newborm requiring an elective endotacheal intubation
    Disease: Version SOC Term Classification Code Term Level
    12.0 10067450 Endotracheal intubation LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005839-20 Sponsor Protocol Number: PPL02 Start Date*: 2007-02-05
    Sponsor Name:Dilafor AB
    Full Title: A randomised, double-blind, placebo-controlled, multicentre trial to access the safety and efficacy of pre-treatment with DF01 during late pregnancy in reducing prolonged labour.
    Medical condition: Pre-treatment during late pregnancy to reduce prolonged labour.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002078-71 Sponsor Protocol Number: 16758 Start Date*: 2010-06-02
    Sponsor Name:Wilhelmina Children's Hospital/UMC Utrecht
    Full Title: Reductie van Hersenschade na “Perinatal Arterial Stroke”of PAS met recombinant humaan Erythropoietine (rhEPO): Een “Proof of Concept” en “Safety” studie
    Medical condition: treatment of perinatal stroke.
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-000566-11 Sponsor Protocol Number: 39-2018 Start Date*: 2018-06-05
    Sponsor Name:University of Oulu
    Full Title: Extremely low gestational age infants' PARAcetamol Study
    Medical condition: Open ductus arteriosus of a premature infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001842-33 Sponsor Protocol Number: 100-2013 Start Date*: 2013-08-19
    Sponsor Name:OYS
    Full Title: The Preterm infants’ Paracetamol Study -- PreParaS
    Medical condition: premature infant
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004868 10036615 Prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    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: 2016-002118-40 Sponsor Protocol Number: PPL07 Start Date*: 2018-02-23
    Sponsor Name:Dilafor AB
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Effect of continuous infusion of Tafoxiparin as an Adjunct Treatment to Oxytocin for up to 36 hours...
    Medical condition: Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004868 10023539 Labor abnormal LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) FI (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-003220-31 Sponsor Protocol Number: 54463 Start Date*: 2016-06-21
    Sponsor Name:VU medical center, Amsterdam
    Full Title: Low dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour – the APRIL study
    Medical condition: Prevention of recurrent spontaneous preterm birth
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (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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