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Clinical trials for Pediatric trauma

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    15 result(s) found for: Pediatric trauma. Displaying page 1 of 1.
    EudraCT Number: 2018-004057-25 Sponsor Protocol Number: RC21/18 Start Date*: 2019-10-02
    Sponsor Name:IRCCS MATERNO INFANTILE BURLO GAROFOLO
    Full Title: Oral Ibuprofene versus oral kethorolac for children with musculoskeletal injury: a double blind randomized controlled study.
    Medical condition: Pain is present in 78% of overall accesses in pediatric emergency rooms and, in most cases, it is acute and secondary to musculoskeletal trauma. Fifthy percent of patients report moderate to severe...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10033472 Pain of extremties LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002282-35 Sponsor Protocol Number: rh-NGF Start Date*: 2020-05-13
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Nerve growth factor in pediatric severe traumatic brain injury : translational and clinical studies on a candidate biomarker and therapeutic drug
    Medical condition: Persistent unresponsive wakefulness syndrome (UWS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10049615 Late effects of head trauma LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003658-34 Sponsor Protocol Number: 9732 Start Date*: Information not available in EudraCT
    Sponsor Name:University Hospital of Montpellier
    Full Title: Non-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study
    Medical condition: traumatic pain
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-018600-87 Sponsor Protocol Number: Peri-Trauma Start Date*: 2010-02-24
    Sponsor Name:AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
    Full Title: POST-OPERATIVE PAIN CONTROL OF PEDIATRIC PATIENTS UNDERWENT ORTHOPEDIC SURGERY: COMPARISON OF INTRAVENOUS ANALGESIA AND ONE-SHOT EPIDURAL LUMBAR NERVE BLOCK.
    Medical condition: POST-OPERATIVE PAIN CONTROL OF PEDIATRIC PATIENTS UNDERWENT ORTHOPEDIC SURGERY
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028395 SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002384-30 Sponsor Protocol Number: ABR81872 Start Date*: 2022-11-15
    Sponsor Name:Erasmus MC - Sophia
    Full Title: Reduction of blood loss in pediatric osteotomies around the hip - A randomized placebo-controlled trial with tranexamic acid –
    Medical condition: Osteotomies around the hip, i.e. proximal femoral and/or pelvic osteotomies (PFPO) in children, for e.g: - hip dysplasia - secondary hip dysplasia - hip incongruenties due to other problems (e.g. p...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001776-21 Sponsor Protocol Number: NCT00687882 Start Date*: 2016-03-10
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für
    Full Title: Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children
    Medical condition: Thrombosis in pediatric patients
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2022-001282-12 Sponsor Protocol Number: NVD003-CLN02-CPT Start Date*: 2022-08-02
    Sponsor Name:Novadip Biosciences
    Full Title: A proof-of-concept study with NVD-003, an autologous osteogenic bone graft, in the treatment of congenital pseudarthrosis of the tibia in pediatric patients
    Medical condition: congenital pseudarthrosis of the tibia (CPT)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-001252-52 Sponsor Protocol Number: CZOL446H2337 Start Date*: 2009-03-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, placebo controlled efficacy and safety trial of intravenous zoledronic acid twice yearly compared to placebo in osteoporotic children treated with glucocort...
    Medical condition: Treatment of osteoporosis in a paediatric population (aged 5 to 17 years old) treated with systemic glucocorticoids (i.v. or oral)
    Disease: Version SOC Term Classification Code Term Level
    18.1 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FI (Prematurely Ended) BE (Completed) DE (Prematurely Ended) PL (Prematurely Ended) Outside EU/EEA HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003453-16 Sponsor Protocol Number: SHP677-304 Start Date*: 2019-07-31
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD)
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) ES (Completed) AT (Completed) IT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003812-22 Sponsor Protocol Number: P903-23 Start Date*: 2011-10-31
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA LT (Completed) LV (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-005281-30 Sponsor Protocol Number: DUR001-306 Start Date*: 2016-11-03
    Sponsor Name:Allergan Ltd.
    Full Title: A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Sk...
    Medical condition: Acute bacterial skin and skin structure infection. For Cohort 5 (from birth to less than 3 months) also patients with sepsis are allowed.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10066412 Staphylococcus aureus skin infection LLT
    20.0 10021881 - Infections and infestations 10037633 Pyoderma (skin infection) LLT
    20.1 10021881 - Infections and infestations 10040873 Skin infection aggravated LLT
    20.0 10021881 - Infections and infestations 10040872 Skin infection PT
    20.0 10021881 - Infections and infestations 10040875 Skin infection pyogenic LLT
    20.0 10021881 - Infections and infestations 10040874 Skin infection NOS LLT
    20.1 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    20.0 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) LT (Prematurely Ended) ES (Prematurely Ended) BG (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-005956-39 Sponsor Protocol Number: RC31/18/0471 Start Date*: 2021-04-06
    Sponsor Name:CHU Toulouse
    Full Title: Treatment of pediatric Post-traumatic Stress Disorder with memory reactivation under the influence of propranolol: A randomized placebo-controlled trial
    Medical condition: Post-traumatic Stress Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10042211 Stress disorders HLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004005-81 Sponsor Protocol Number: GC1801 Start Date*: 2021-01-25
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemi...
    Medical condition: Congenital Afibrinogenaemia and Severe Hypofibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-002236-24 Sponsor Protocol Number: 261302 Start Date*: 2014-03-27
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A Phase 3b Continuation study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients with Severe Hemophilia A
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) LT (Completed) BG (Completed) SE (Completed) GB (Completed) CZ (Completed) AT (Completed) NL (Completed) DE (Completed) ES (Completed) PL (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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