A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants Save

Date Added
September 26th, 2017
PRO Number
Pro00066901
Researcher
Andrew Atz
Keywords
Children's Health, Drug Studies, Infant, Infectious Diseases, Lung, Pediatrics
Summary

This is a Randomized , Double blinded study to evaluate how effective a single dose of experimental drug called MEDI8897 is at preventing lung disease caused by RSV disease in healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days.This study also evaluate safety, tolerability and pharmacokinetics (PK) of MEDI8897 in healthy preterm infants compared with placebo.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
834-792-1213
choudhar@musc.edu

Trials and ReseArch NetworkS FOR More South Carolina (TRANSFORM SC) Child Health Recruitment Registry Save

Date Added
June 9th, 2017
PRO Number
Pro00063569
Researcher
Andrew Atz
Keywords
Asthma, Autism, Children's Health, Diabetes, Obesity
Summary

The TRANSFORM network is focused on improving child health outcomes in SC through research on conditions of highest priority for future generations. These include conditions like asthma, autism, diabetes, obesity and early childhood outcomes. To accelerate research study recruitment activities for future projects that TRANSFORM sites may participate in, the TRANSFORM network sites will create a research recruitment registry of families interested in volunteering for research. Participants will enter their own as well as their child(ren)'s information into the electronic registry which can be used to identify people to contact for future studies.

Institution
MUSC
Recruitment Contact
Samantha Renaud
803-576-5913
renaud2@mailbox.sc.edu

Dyslipidemia of Obesity Intervention Trial DO IT! Save

Date Added
June 6th, 2017
PRO Number
Pro00037680
Researcher
Andrew Atz
Keywords
Children's Health, Obesity
Summary

This trial of pitavastatin will determine efficacy and safety in this high risk population, and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-792-1213
alsarraf@musc.edu

A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention Save

Date Added
December 13th, 2016
PRO Number
Pro00058654
Researcher
Andrew Atz
Keywords
Cardiovascular, Drug Studies, Pediatrics
Summary

This is a prospective, randomized, open-label, Phase II, multi-center clinical trial for pediatric subjects with congenital or acquired heart disease who are on blood thinners. Subjects will be assigned by chance (2:1) to apixaban,vitamin K antagonist or low molecular weight heparin.

Recruitment will start first for subjects 2 years old to less than 18 years old. Recruitment for subjects from 0 to less than 2 years of age will be delayed until study data from the 2 to less than 18 years of age is analyzed.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes Save

Date Added
July 14th, 2016
PRO Number
Pro00056838
Researcher
Andrew Atz
Keywords
Children's Health
Summary

We will combine state-of-the-art brain imaging techniques in 140 Single Ventricle Reconstruction Trial (SVR) III patients and 100 control subjects with innovative brain connectome or ?graph? analyses to determine if brain connectivity graph measurements will provide novel neuroimaging biomarkers for neurodevelopmental disabilities and improve our understanding of their inciting mechanisms in the SVR survivors. Only 6 of the SVR III patients and no controls will be enrolled at MUSC.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
843-792-1213
tecklenb@musc.edu

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL) Save

Date Added
July 5th, 2016
PRO Number
Pro00054936
Researcher
Andrew Atz
Keywords
Adolescents, Cardiovascular, Drug Studies, Pediatrics
Summary

Multiple studies have shown a progressive decline in measured aerobic exercise capacity during adolescence in survivors of the Fontan procedure. When maximal oxygen consumption falls below a threshold of approximately 50% of predicted for age and gender the risk of cardiopulmonary failure, death, or need for heart transplantation increases significantly. A therapy which improves or reduces this observed decline in exercise capacity might forestall the onset of heart failure and prolong transplant-free survival. This is a randomized, double-blind, placebo-controlled clinical trial of a 6-month (26 week) treatment with udenafil (87.5 mg twice daily). The primary efficacy measurement will be improvement in aerobic exercise performance relative to baseline. The secondary efficacy measurements will examine 1) Improvement on echocardiographic indices of systolic and diastolic ventricular performance relative to baseline; 2) Improvement on endothelial function relative to baseline; 3) Improvement on serum brain-type natriuretic peptide (BNP) level, a biomarker of heart failure, relative to baseline; 4)To determine if six months of treatment with oral udenafil will alter functional health status in adolescents following the Fontan procedure. Safety will be assessed by monitoring adverse events and vital signs, clinical laboratory test results, 12-lead ECG, and physical examinations.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
843-792-9454
tecklenb@musc.edu

Pharmacokinetics of Clindamycin and Trimethoprim-Sulfamethoxazole in Infants and Children Save

Date Added
October 6th, 2015
PRO Number
Pro00046417
Researcher
Andrew Atz
Keywords
Pediatrics
Summary

This is a PK and safety study of clindamycin and TMP-SMX for prophylaxis or treatment in infants and children with confirmed or suspected infection.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care Save

Date Added
June 5th, 2012
PRO Number
Pro00016550
Researcher
Andrew Atz
Keywords
Cardiovascular, Genetics, Heart, Pediatrics
Summary

The majority of drugs administered to children are used off label and PK studies to define appropriate dosing are lacking across pediatric age groups. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard of care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per standard of care as prescribed by their treating caregiver.
This study will serve as a tool to better understand drug exposure in children receiving drugs per standard of care. The data collected through this initiative will provide valuable PK and dosing information drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-1213
choudhur@musc.edu

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