Clinical trials: Pediatric Trauma
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Scorpion Sting Envenomation
Establishment of Natural History of Scorpion Envenomation
This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom.
- Trial name
- NCT00696683
- Testing
- None, this is an observational study
- Where
- United States
- Volunteers
- 97 people
- Sponsor
- Instituto Bioclon S.A. de C.V.
Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Trial name
- PETIT (NCT06750536)
- Testing
- MiniLung petite kit combined with the Xenios console
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
Spinal Cord Injury (SCI)
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal…
- Trial name
- NCT06772077
- Testing
- Rehabilitation treatment with ATLAS2030
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- MarsiBionics
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
Athletic Injuries
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.
- Trial name
- NCT02132247
- Testing
- Diclofenac hydroxyethylpyrrolidine
- Where
- 10 sites in United States
- Volunteers
- 104 people
- Sponsor
- IBSA Institut Biochimique SA
Osteogenesis Imperfecta
Bisphosphonate Treatment of Osteogenesis Imperfecta
The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.
- Trial name
- NCT00063479
- Testing
- Zoledronic Acid
- Where
- 10 sites in United States
- Volunteers
- 158 people
- Sponsor
- Novartis Pharmaceuticals
Myocardial Ischemia, Heart Defects, Congenital
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric…
- Conditions
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- Trial name
- NCT07785141
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Duchenne Muscular Dystrophy
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory…
- Trial name
- SHIELD DMD (NCT06450639)
- Testing
- Satralizumab
- Where
- 18 sites in United States, Denmark and 4 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Ankle Fractures, Knee Fractures
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of…
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Trial name
- NCT07473947
- Testing
- Fracture fixation operation
- Where
- Finland
- Volunteers
- 80 people
- Sponsor
- Inion Oy
Intracranial Hypertension
Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external…
- Trial name
- NCT02695264
- Testing
- HS-1000 recording
- Where
- United States
- Sponsor
- HeadSense Medical
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Acute Renal Failure (ARF), Acute Kidney Injury (AKI)
Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set.
- Conditions
- Acute Renal Failure (ARF), Acute Kidney Injury (AKI), Fluid Overload in Dialysis Patients
- Trial name
- NCT06633029
- Testing
- Prismaflex HF20
- Where
- 5 sites in United States
- Volunteers
- 59 people
- Sponsor
- Vantive Health LLC
Skin Wound, Burns
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns.
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Trial name
- StrataSTEPS (NCT05517902)
- Testing
- StrataGraft
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Scorpion Sting Envenomation
Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients
There is no FDA approved therapy for the treatment of scorpion envenomation, Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening.
- Trial name
- NCT00685230
- Testing
- Antivenin Centruroides (scorpion) equine immune F(ab)2
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Instituto Bioclon S.A. de C.V.
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Neurogenic Detrusor Overactivity
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity.
- Trial name
- NCT00712322
- Testing
- Darifenacin
- Where
- 12 sites in United States, Colombia
- Volunteers
- 35 people
- Sponsor
- Warner Chilcott