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Clinical trials for Neonatal hypoglycemia

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   44332   clinical trials with a EudraCT protocol, of which   7365   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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    17 result(s) found for: Neonatal hypoglycemia. Displaying page 1 of 1.
    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: 2012-000814-13 Sponsor Protocol Number: ML7981 Start Date*: 2012-03-16
    Sponsor Name:University Hospital Leuven
    Full Title: Glibenclamide treatment in hypotonia-cystinuria syndrome
    Medical condition: Hypotonia-cystinuria syndrome/PREPL deficiency
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-004680-31 Sponsor Protocol Number: 2018-004680-31 Start Date*: 2019-08-16
    Sponsor Name:Lene Ringholm
    Full Title: A randomised controlled trial comparing the effect of the faster-acting insulin analog - insulin Fiasp® – versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during p...
    Medical condition: Type 1 and type 2 diabetes during pregnancy and lactation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10012614 Diabetes mellitus NOS LLT
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-000043-74 Sponsor Protocol Number: PNAS0122 Start Date*: 2023-07-27
    Sponsor Name:Medical University of Vienna
    Full Title: Defining and predicting neonatal inadaptation after gestational exposure to antidepressants: longitudinal exploratory analysis of psychoneuroendocrine risk factors and complications
    Medical condition: major depressive disorder poor neonatal adaptation syndrome (after antidepressant use during pregnancy)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001726-22 Sponsor Protocol Number: COLIGROW Start Date*: 2022-12-12
    Sponsor Name:Dr. Ignacio Herraiz García
    Full Title: COok's ballon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study).
    Medical condition: Induction of term pregnancies with fetal growth restriction.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004545-24 Sponsor Protocol Number: ZP4207-17103 Start Date*: 2018-12-29
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congen...
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    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: 2008-005892-83 Sponsor Protocol Number: WCH/2008/001 Start Date*: 2009-01-14
    Sponsor Name:Epsom and St Helier University Hospitals NHS Trust
    Full Title: Does metformin improve pregnancy outcomes [ incidence of LGA (≥90% birth weight centile) babies onset of maternal Gestational Diabetes, hypertension, PET, shoulder dystocia, admission to SCBU) in o...
    Medical condition: Obesity in pregnancy. Obesity in pregnancy has been identified by Confidential Enquiry into Maternal And Child Health (CEMACH) (2008-2011) as a major health risk to mother and baby.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004830-14 Sponsor Protocol Number: UX007-CL201 Start Date*: 2014-02-26
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: An Open-Label Phase 2 Study to Assess Safety and Clinical Effects of UX007 in Subjects with Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)
    Medical condition: Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004547-21 Sponsor Protocol Number: ZP4207-17109 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004546-15 Sponsor Protocol Number: ZP4207-17106 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002836-97 Sponsor Protocol Number: 240193 Start Date*: 2012-12-20
    Sponsor Name:Tartu University Hospital
    Full Title: Pharmacokinetics of penicillin, ampicillin and gentamicin in near- term and full-term neonates
    Medical condition: neonatal sepsis, pneumonia and meningitis
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002263-15 Sponsor Protocol Number: LIXISL07016 Start Date*: 2014-10-10
    Sponsor Name:sanofi aventis S.p.A
    Full Title: Effects of GLP-1 Receptor Agonist Lixisenatide on Post-prandial Lipid Profile in Obese Type 2 Diabetic Patients
    Medical condition: Effect of GLP-1 receptor agonist lixisenatide on post-prandial lipid profile in obese patients
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-005031-32 Sponsor Protocol Number: Diabetes2017 Start Date*: 2017-10-10
    Sponsor Name:Pirkanmaan sairaanhoitopiiri
    Full Title: Metformin use to improve pregnancy outcome in women with type 1 diabetes. A double-blind placebo-controlled multicenter study.
    Medical condition: Pregnancy of a women dealing with type 1 diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10012594 Diabetes LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000322-19 Sponsor Protocol Number: UX007-CL202 Start Date*: 2016-06-06
    Sponsor Name:Ultragenyx Pharmaceutial Inc.
    Full Title: An Open-label Long-Term Safety and Efficacy Extension Study in Subjects with Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Previously Enrolled in UX007 or Triheptanoin Studies
    Medical condition: Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2016-003023-30 Sponsor Protocol Number: 401GSDIA01 Start Date*: 2018-11-27
    Sponsor Name:Ultragenyx Pharmaceutical, Inc.
    Full Title: A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Glucose-6-Phosphatase (G6Pase) in Adults with Glycogen Storage Dise...
    Medical condition: Glycogen Storage Disease Type Ia (GSDIa).
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10056911 Glycogen storage disease type IA LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-004184-12 Sponsor Protocol Number: DTX401-CL301 Start Date*: 2022-08-22
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated Virus Serotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With Glycogen Storage Disease Type Ia....
    Medical condition: Glycogen Storage Disease Type Ia (GSDIa).
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10056911 Glycogen storage disease type IA LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Trial now transitioned) IT (Trial now transitioned) DK (Trial now transitioned) PT (Completed) DE (Trial now transitioned) NL (Trial now transitioned)
    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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