Clinical trials: Pediatrics
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
- Trial name
- NCT04436822
- Testing
- Continuous Glucose Monitoring
- Where
- 18 sites in United States, China
- Volunteers
- 317 people
- Sponsor
- Medtronic MiniMed, Inc.
Myopia
Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors. Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting…
- Trial name
- MODERATO (NCT07028827)
- Testing
- 0.05% atropine eye drops, 0.025% atropine eye drops
- Where
- 11 sites in Albania, Italy and 3 more
- Volunteers
- 234 people
- Sponsor
- Ocus Innovation Ireland Limited
Controlled Asthma
Modelling of the Upper Airway in Children With Controlled Asthma
Asthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric…
- Trial name
- NCT01594151
- Testing
- Cone Beam Computed Tomography
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- FLUIDDA nv
Depressive Disorder, Major
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition)…
- Trial name
- NCT02709746
- Testing
- Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20 mg/day
- Where
- 124 sites in United States, Bulgaria and 17 more
- Volunteers
- 784 people
- Sponsor
- H. Lundbeck A/S
Pneumococcal Infections
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00452790
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 12 sites in India
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Pneumonia, Pneumonia in Children
Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia
The main questions this study aims to answer are: Does using probiotic nasal spray (LiveSpo Navax containing Bacillus subtilis and Bacillus clausii, 1x10^9 CFU/mL), with or without oral probiotics (LiveSpo Pregmom containing…
- Trial name
- NCT07399717
- Testing
- Navax, Navax-PregMom
- Where
- Vietnam
- Volunteers
- 330 people
- Sponsor
- Anabio R&D
Infection, Human Immunodeficiency Virus
PENTA Fosamprenavir Study
Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other…
- Trial name
- NCT01077635
- Testing
- Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
Pediatrics, Muscle Spasticity
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
- Conditions
- Pediatrics, Muscle Spasticity, Cerebral Palsy, Stroke
- Trial name
- NCT01603615
- Testing
- Botulinum Toxin Type A
- Where
- 48 sites in United States, Canada and 7 more
- Volunteers
- 220 people
- Sponsor
- Allergan
Phenylketonuria
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with…
- Trial name
- SPARK (NCT01376908)
- Testing
- Kuvan®, Phenylalanine (Phe)-restricted diet
- Where
- 22 sites in Austria, Belgium and 7 more
- Volunteers
- 56 people
- Sponsor
- BioMarin Pharmaceutical
Diabetes Mellitus
FreeStyle Libre Glucose Monitoring System Paediatric Study
The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.
- Trial name
- SELFY (NCT02821117)
- Testing
- FreeStyle Libre Flash Glucose Monitoring System
- Where
- 10 sites in Germany, Ireland and 1 more
- Volunteers
- 76 people
- Sponsor
- Abbott Diabetes Care
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50…
- Trial name
- NCT00495521
- Testing
- 4-Aminosalicylic acid extended release granules
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jacobus Pharmaceutical
HIV-1 Infection
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term…
- Trial name
- NCT00743340
- Testing
- Emtricitabine
- Where
- 2 sites in South Africa
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
Respiratory Tract Infections
ProbioKid as Prevention Among Kids With Frequent URTI
This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.
- Trial name
- NCT04525040
- Testing
- ProbioKid®, Pragmatic comparator
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Lallemand Health Solutions
Sleep Apnea
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
- Trial name
- NCT04031950
- Testing
- Novel wearable paediatric device
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Acurable Ltd.
Asthma
Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma
The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild persistent asthma following a…
- Trial name
- NCT00270348
- Testing
- ciclesonide
- Volunteers
- 450 people
- Sponsor
- Sanofi
Robotic Surgical Procedures in Pediatric Urology
Versius Paediatrics Study
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device)…
- Trial name
- NCT06539442
- Testing
- Versius Surgical System
- Where
- 3 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- CMR Surgical Ltd
Pharmacokinetics
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects
Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the…
- Trial name
- NCT02957396
- Testing
- Finerenone (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet, Finerenone (BAY94-8862): 20 mg suspension
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Impetigo
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin Ointment 20 mg/g TID (three…
- Trial name
- NCT04287777
- Testing
- Mupirocin gel, Mupirocin ointment
- Where
- 20 sites in Spain
- Volunteers
- 467 people
- Sponsor
- Reig Jofre Group