Early Power Mobility Study for Children with Neuromuscular Disorders + save

Date Added
March 19th, 2014
PRO Number
Pro00022440
Researcher
Patricia Coker
Keywords
Children's Health, Physical Therapy
Summary

Power wheelchairs are defined as ‘Wheelchairs powered by electricity that provide mobility and body support for individuals with limited ability to walk’ (Shoemaker et al., 2010). For the purposes of this study, the term power mobility is any battery powered equipment used for mobility by children with disabilities. This can include powered ride-on-toys (e.g. Boss car, Cooper car), powered scooter-boards and powered standing devices (e.g. Gobot). This study seeks to expand on the new literature being published on the use of commercially available powered ride-on-toys to assist with the early mobility of children born with movement disorders. Children with neuromuscular impairments have significantly decreased early mobility which greatly affects their opportunities to explore their physical and social environment (Tefft, Guerette, & Furumasu, 1999; Uchiyama, Anderson, & Campos, 2008). The commercially available ride-on-toys could be used in the clinic, home, community, or school settings to improve independent mobility and are a low cost alternative to other mobility devices (Huang & Galloway, 2012). In addition, these devices provide a novel therapeutic tool to examine and/or treat body function level impairments such as cause-effect learning and head/upper extremity/trunk/lower extremity strength and control (Ragonesi & Galloway, 2012). The utilization of early power mobility allows for important early exploration and learning and may have tremendous effect on later perceptual, cognitive, social, and quality of life outcomes for children with movement disorders.

Institution
MUSC
Recruitment Contact
Patricia Coker
843-792-7491
cokerpc@musc.edu

Using Health Status to Measure Care Coordination Efficacy + save

Date Added
March 12th, 2014
PRO Number
Pro00030602
Researcher
Johnette Simmons
Keywords
ADD/ADHD, Adolescents, Aging, Autism, Brain, Cancer, Cerebral Palsey, Children's Health, Dementia, Depression, Diabetes, Geriatrics, Heart, Hypertension/ High Blood Pressure, Mental Health, Obesity, Pediatrics, Rehabilitation Studies, Spinal Cord, Stroke
Summary

On March 23, 2010, President Barack Obama of the United States of America, signed into law the Patient Protection and Affordable Care Act commonly referred to as health reform. This bill calls immediate attention to better coordinated care between providers of health care and ancillary services. While the health reform law is new, the concept of care coordination in the practical sense is familiar to several health and human service disciplines, such as behavioral healthcare, developmental disability systems of care, medical home models, disease management programs, case management programs, long term care Medicaid waivers, and large healthcare organizations. The aim of this study is to understand what consumers and families expect from care coordination programs and services, and how programs should be designed to ensure the most benefit

Institution
MUSC
Recruitment Contact
Johnette Simmons
843-576-1408
sinjoh@musc.edu

South Carolina Children's Educational Surveillance Study + save

Date Added
March 4th, 2014
PRO Number
Pro00015374
Researcher
Laura Carpenter
Keywords
Autism, Children's Health
Summary

We will conduct a screening and direct assessment study in the general population in an area already undergoing monitoring by ADDM. Specifically, all 8-year-olds in a three county region of South Carolina (n=8,000) will be screened for ASD, and those found to be at risk for ASD will be invited to participate in an in-depth diagnostic assessment. Evidenced-based strategies will be implemented to maximize participation in both the screening and diagnostic phases of the study to improve the accuracy of the findings. ASD prevalence estimates will be calculated using the number of children aged 8 years residing in the study area as the denominator, and the number of children identified as cases as the numerator, with adjustments made for missing data from nonparticipants. Prevalence estimates will be provided using both traditional ADDM and SUCCESS methods. Factors contributing to
differences in ASD prevalence estimates by methodology (e.g. sex, race/ethnicity, SES, previous diagnoses, behaviors, degree of impairment, co-morbidities) will be examined. Additionally we will compare prevalence using the DSM-Iv and DSM-5 criteria.

Institution
MUSC
Recruitment Contact
Walter Jenner
843-532-4992
jennerw@musc.edu

Pharmacokinetics of Multiple Dose Methadone in Children + save

Date Added
January 7th, 2014
PRO Number
Pro00029787
Researcher
Andrew Atz
Keywords
Children's Health, Drug Studies, Pediatrics
Summary

Selection of the correct drug dose is the most important decision in assuring optimal pharmacotherapy. Defining an optimal regimen requires a clear understanding of the drug’s PK, pharmacodynamics (PD), and for methadone, pharmacogenomic profiles. Understanding these characteristics for drugs used in children is imperative to determine optimal dose regimens across the pediatric age continuum.

Institution
MUSC
Recruitment Contact
Hibah Al Nasiri
843-792-0080
alnasiri@musc.edu

Pressure Volume Loop Analysis in Fontan Patients + save

Date Added
December 3rd, 2013
PRO Number
Pro00021772
Researcher
Ryan Butts
Keywords
Adolescents, Children's Health, Heart, Pediatrics
Summary

The goal of this study is to better understand single ventricle circulation after its final palliation, the Fontan procedure. Each specific aim of the project directly affects current knowledge and/or aids future research in this population. In regards to Aim1, a better understanding the impaired responses to stress in single ventricle circulation will help direct future research on ways to improve quality of life as well as help direct medical and surgical therapies in this population. In regards to Aim 2, the mechanism that leads to improved exercise capacity with PDE5 inhibition will be elucidated. These three aims all compliment the overall goal of understanding the mechanisms that lead to heart failure in this high risk population.

Institution
MUSC
Recruitment Contact
Ryan Butts
843-792-9146
butts@musc.edu

Effectivness of Heliox as adjunct therapy with High Flow Nasal Cannula(HFNC) in Children with Respiratory Distress + save

Date Added
November 21st, 2013
PRO Number
Pro00028732
Researcher
Mary Cantrell
Keywords
Asthma, Breathing, Children's Health, Pediatrics, Pulmonary
Summary

Children admitted to PICU with respiratory distress that require HFNC therapy will be eligible for entery. Patients will be randomly assigned into 2 arms of study. One arm will be standard oxygen therapy delivered via HFNC. Second arm will be HFNC with Heliox added. Patients heart rate, respiratory rate, O2 saturations, FIO2 and modified pulmonary Index score(mpis) distress score will be recorded at treatment intervals.

Institution
Spartanburg
Recruitment Contact
Mary Cantrell
864-809-2875
mcantrell@srhs.com

A MULTICENTER, OBSERVATIONAL REGISTRY OF PEDIATRIC FEMALE PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY RECEIVING SUPPRELIN® LA (HISTRELIN ACETATE), A HYDROGEL SUBCUTANEOUS IMPLANT PROTOCOL NO.: EN3326-403 + save

Date Added
November 8th, 2013
PRO Number
Pro00027444
Researcher
Deborah Bowlby
Keywords
Children's Health
Summary

This is a Phase IV multicenter, observational study of 100 pediatric female patients with CPP being treated with SUPPRELIN LA.Sites will extract relevant historical study information from the patients' medical charts and will enter data into an electronic data collection (EDC) system. Additional study information will be collected at the time of routine clinical visits (standard of care)and/or by telephone contact to obtain date of menses. (No study procedures are to be performed only data collection)

Institution
MUSC
Recruitment Contact
Amanda Blue
843-792-1005
blueae@musc.ede

Ketamine in Chronic Kid’s Pain + save

Date Added
November 5th, 2013
PRO Number
Pro00019935
Researcher
Amy-lee Bredlau
Keywords
Children's Health, Pain
Summary

We now know that oral ketamine is safe in children with chronic pain, but we do not know which dose (if any) has the potential to control chronic pain in children. This study is a randomized, placebo-controlled, double blinded study that is designed to select the most appropriate dosage of oral ketamine for development as a medicine for control of chronic pain in children. Once this dosage is selected, oral ketamine can be further developed for control of chronic pain in children.

Institution
MUSC
Recruitment Contact
Patricia Infinger
843-792-7857
infingep@musc.edu

A 4 Year Blinded-Outcomes Follow up Study of Patients Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-204 + save

Date Added
October 22nd, 2013
PRO Number
Pro00029095
Researcher
Carol Wagner
Keywords
Children's Health, Infant
Summary

This is a multicenter 48-52 month blinded-outcomes follow up study of subjects who received stannsoporfin or placebo in clinical trial 64,185-204. This clinical trial consists of clinic visits over 4 year period. The developmental tools used in this trial will identify children who are developmentally delayed or at risk for delay.

Institution
MUSC
Recruitment Contact
Deanna Fanning
843-792-7021
fanningd@musc.edu

Direct Measurement of Tissue Plasmin Activity in Infants and Children Undergoing Cardiothoracic Surgery - a Preliminary Feasibility Study + save

Date Added
September 20th, 2013
PRO Number
Pro00011449
Researcher
Ilka Theruvath
Keywords
Cardiovascular, Children's Health
Summary

Extensive blood loss and multiple blood transfusions are a major source of patient complications during and after infant cardiac surgery. The activation of the fibrinolytic system (an enzyme sytem that breaks down blood clots) during surgery is thought to be a main cause of blood clot instability in these patients. Although medications that inhibit this system are routinely used, they also display very variable efficacy and can cause serious side effects. The primary hypothesis of this study is that direct measurement of the activation status of the fibrinolytic system directly inside local tissue (e.g. muscle or wound surfaces) will enable physicians to better evaluate the blood clotting ability of a pediatric heart surgery patient and will substantially improve diagnostic accuracy and drug dosing, thereby reducing the observed side effects such as kidney injury and increased risk of thrombosis.

Institution
MUSC
Recruitment Contact
Peggy Edgerton
(843)792-1869
kotlowpe@musc.edu