Clinical trials: Pediatrics
Hyponatremia
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid…
- Trial name
- NaCrICh (NCT01301274)
- Testing
- hypotonic, isotonic
- Where
- Argentina
- Volunteers
- 66 people
- Sponsor
- Hospital General de Niños Pedro de Elizalde
Non-Alcoholic Fatty Liver Disease
Gemcabene for the Treatment of Pediatric NAFLD
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by…
- Trial name
- NCT03436420
- Testing
- Gemcabene
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Gastroesophageal Reflux
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
- Trial name
- NCT01045096
- Testing
- Dexlansoprazole
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Takeda
Depression
Vortioxetine to Prevent Return of Symptoms in Children With Depression
The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
- Trial name
- NCT05014919
- Testing
- Vortioxetine
- Where
- 17 sites in United States, Colombia and 5 more
- Volunteers
- 35 people
- Sponsor
- H. Lundbeck A/S
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children…
- Trial name
- mentor™5 (NCT01253811)
- Testing
- catridecacog
- Where
- 4 sites in United States, Israel and 1 more
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Rare Diseases
FACE for Children With Rare Diseases
Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity.
- Trial name
- FACE-Rare (NCT04855734)
- Testing
- FAmily CEntered (FACE) pACP Intervention
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Children's National Research Institute
Femoral Fractures, Pain, Postoperative
Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture
The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.
- Trial name
- NCT01294098
- Testing
- Marcaine
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Washington University School of Medicine
Ventilators, Mechanical, Work of Breathing
Effort of Breathing Guided Ventilator Protocol
This pilot study tests the feasibility of using a computerized ventilator management protocol seeking to encourage lung protective ventilation during the acute phase of ventilation, and esophageal manometry based titration of…
- Trial name
- EOBvent (NCT02989246)
- Testing
- Ventilator protocol, Esophageal Catheter
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Children's Hospital Los Angeles
Type 2 Diabetes
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes.
- Trial name
- AWARD-PEDS (NCT02963766)
- Testing
- Dulaglutide
- Where
- 61 sites in United States, Brazil and 9 more
- Volunteers
- 154 people
- Sponsor
- Eli Lilly and Company
Analgesia After Pacemaker, AICDS Implantation Pediatrics
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a…
- Trial name
- NCT04184349
- Testing
- LA group, B Group
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
Malnutrition, Child
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at…
- Trial name
- NCT03563222
- Testing
- Smoflipid, Intralipid, 20%
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fresenius Kabi
Anesthesia, Depth of Hypnosis Monitoring
The Effect of DSA on Recovery of Anaesthesia in Children
In this randomised, blinded study, we will investigate the influence of DSA on recovery from general anaesthesia. DSA monitoring provides continuous information on depth of hypnosis.
- Trial name
- DSA-RCT-1 (NCT05525104)
- Testing
- Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)
- Where
- Netherlands
- Volunteers
- 112 people
- Sponsor
- Erasmus Medical Center
Asthma
Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3
This study will enroll parents/guardians of children who receive treatment at one of the pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS) network or at the Children's Hospital of…
- Trial name
- NCT01966068
- Testing
- MyAsthma Web Portal
- Where
- 2 sites in United States
- Volunteers
- 294 people
- Sponsor
- Children's Hospital of Philadelphia
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
Feasibility, Insulin
The Metabolic Effects of Breaks in Sedentary Time
The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or without breaks and/or structured physical activity) result in measurable changes in metabolic health in children and youth.
- Conditions
- Feasibility, Insulin, Glucose, Lipids
- Trial name
- NCT01398059
- Testing
- Sedentary, Sedentary With Breaks, Sedentary With Breaks and Physical Activity
- Where
- Canada
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Eastern Ontario
Epilepsy; Paediatric Partial Onset Seizures
Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)
The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.
- Trial name
- NCT00566254
- Testing
- Zonisamide
- Where
- 43 sites in Belgium, Estonia and 7 more
- Volunteers
- 207 people
- Sponsor
- Eisai Inc.
Health Education, Sudden Infant Death
Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance
The delivery of anticipatory guidance is an essential component of pediatric practice. Given the large amount of information to be shared during each encounter and the limited time available, there is a need for an effective and…
- Trial name
- NCT01014169
- Testing
- Note taking
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
HIV Infections
Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV.
- Trial name
- P1060 (NCT00307151)
- Testing
- Lamivudine, Lopinavir/ritonavir, Nevirapine
- Where
- 10 sites in India, Malawi and 5 more
- Volunteers
- 452 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Diabetes, Diabetes Mellitus, Type 1
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily…
- Trial name
- MIXING (NCT00542620)
- Testing
- insulin detemir, insulin aspart
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S
Chronic Iron Overload
Pharmacokinetic Study of Deferiprone in Paediatric Patients
Deferiprone (DFP) is the most extensively studied oral iron chelator to date. It has been authorised in Europe in 1999 for the treatment of iron overload in patients with beta-thalassaemia major when DFO is contraindicated or…
- Trial name
- DEEP-1 (NCT01740713)
- Testing
- Deferiprone, dose level 1, Deferiprone, dose level 2, Deferiprone, dose level 3
- Where
- 7 sites in Cyprus, Egypt and 1 more
- Volunteers
- 23 people
- Sponsor
- Consorzio per Valutazioni Biologiche e Farmacologiche