Clinical trials: Surgery in Children
Ocular Inflammation
KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children.
- Trial name
- NCT03596723
- Testing
- KPI-121 1%, Prednisolone acetate
- Where
- 4 sites in United States
- Volunteers
- 2 people
- Sponsor
- Kala Pharmaceuticals, Inc.
Heart Defects, Congenital, Hypertension, Pulmonary
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Trial name
- NCT00335244
- Testing
- L-citrulline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
Analgesia
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years.
- Trial name
- NCT04897750
- Testing
- CT001
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Cessatech A/S
Hearing Loss, Conductive
Evaluation of the BHX Implant in Children with a BAHS
The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice.
- Trial name
- NCT03742089
- Testing
- Bone Anchored Hearing Surgery
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
Post-Operative Pain
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
After surgery on his penis, your child will probably have some pain. The investigators will give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally), for pain.
- Trial name
- LMX-4 (NCT00847093)
- Testing
- LMX4
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ferndale Laboratories, Inc.
Achondroplasia
A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia
Study 111-209 is a Phase 2 randomized, open-label clinical trial of BMN 111 in infants and young children with a diagnosis of Achondroplasia at a heightened risk of requiring cervicomedullary decompression surgery
- Trial name
- NCT04554940
- Testing
- vosoritide
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 20 people
- Sponsor
- BioMarin Pharmaceutical
Post Operative Pain
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.
- Trial name
- NCT05315479
- Testing
- N1539
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Baudax Bio
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical…
- Conditions
- Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children, Pyeloplasty, Ureteral Reimplantation
- Trial name
- NCT07530133
- Testing
- Thoracic and Abdominal Endoscopic Surgery System
- Where
- 3 sites in China
- Volunteers
- 64 people
- Sponsor
- Hangzhou Kangji Weijing Medical Robotics Co., Ltd.
Cataract
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
- Trial name
- NCT01475643
- Testing
- Loteprednol etabonate, Prednisolones acetate
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Bausch & Lomb Incorporated
Limb Length Discrepancy
A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.
This study will look at how safe and effective limb lengthening surgeries are for the femur and tibia in children 12 years old and younger.
- Trial name
- NCT06714110
- Testing
- Intramedullary Limb Lengthening Device, External Fixator Limb Lengthening Device
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NuVasive
Pain
Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery
Study to assess the analgesic efficacy in the prevention of postoperative pain in children undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of Metamizol in this group of patients.
- Trial name
- NCT02184273
- Testing
- Magnesium metamizol
- Volunteers
- 122 people
- Sponsor
- Boehringer Ingelheim
Congenital Heart Malformations
Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
- Trial name
- NCT07381530
- Testing
- heart will be treated with Custodiol-N, heart will be treated with Custodiol
- Where
- 3 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Congenital Heart Disease in Children
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe…
- Trial name
- NCT05647161
- Testing
- BAX602, No Intervention
- Where
- 6 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Baxter Healthcare Corporation
Moderate to Severe Acute Postoperative Pain
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within…
- Trial name
- NCT02221674
- Testing
- Tapentadol
- Where
- 7 sites in United States, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Grünenthal GmbH
Von Willebrand Disease
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
The main aim of the study is to check effectiveness, side effects, and tolerability of vonicog alfa (recombinant von Willebrand factor [rVWF]), with or without ADVATE, in the treatment and control of nonsurgical bleeding events…
- Trial name
- NCT02932618
- Testing
- Vonicog alfa, Antihemophilic Factor (Recombinant)
- Where
- 46 sites in United States, Austria and 11 more
- Volunteers
- 47 people
- Sponsor
- Baxalta now part of Shire
Cataract in Child
FLACS in Pediatric Patients Using FEMTO LDV-Z8
This study is a single center prospective observational case series. The framework of this clinical investigation is post market clinical follow up of pediatric FLACS using the Femto LDV Z8.
- Trial name
- NCT05241756
- Testing
- FLACS using FEMTO LDV-Z8
- Where
- Belgium
- Volunteers
- 12 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Post Cardiac Surgery
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients.
- Trial name
- NCT01662141
- Where
- Sweden
- Volunteers
- 33 people
- Sponsor
- Transonic Systems Inc.