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

Date Added
July 13th, 2015
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

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Save

Date Added
June 16th, 2015
PRO Number
Pro00011805
Researcher
Robert Stuart
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
?Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
?Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-2708
simonsjl@musc.edu

Gold-standard Measures of Diastolic Function in Single Ventricle Physiology Prior to Stage 3 Palliation: Correlations with Echocardiography and Relationship to Outcomes Save

Date Added
June 8th, 2015
PRO Number
Pro00034502
Researcher
Shahryar Chowdhury
Keywords
Cardiovascular, Children's Health, Heart, Pediatrics
Summary

In recent decades, the intense interest in the contribution of diastolic dysfunction to adult heart failure has resulted in a number of echocardiographic methods to evaluate diastolic function. To evaluate their accuracy, echocardiographic measurements of diastolic function have been validated with gold-standard measures derived from micromanometer pressure analysis in the adult heart failure population. However, no studies have assessed the accuracy of echocardiographic measures of diastolic function in the single ventricle population. Also, the relationship between echocardiographic measures of diastolic function and outcomes in the single ventricle population ? an exercise necessary to determine their clinical usefulness - has not been investigated. The specific aims of this study seek to validate the accuracy and clinical utility of these non-invasive indices in the single ventricle population

Institution
MUSC
Recruitment Contact
Patricia Infinger
803-792-7857
infingep@musc.edu

Prostaglandin Metabolites in Premature Infants Save

Date Added
June 2nd, 2015
PRO Number
Pro00033380
Researcher
Matthew Halliday
Keywords
Cardiovascular, Children's Health, Infant, Pediatrics
Summary

The patent ductus arteriosus (PDA) is a blood vessel that is essential to the life of a fetus while in the womb. However, the PDA can cause significant adverse effects on an infant after he/she is born if the PDA does not close in a matter of days to weeks. Current therapy to treat a PDA in infants inhibits a chemical in the body called prostaglandins which in turn causes constriction and closure of the PDA. Unfortunately the current therapy is not always effective and has significant side effects including damage to the kidneys. Our study will look at prostaglandin levels in the urine of infants before and after treatment to hopefully identify if there is a way to predict who will respond to the current therapy. We will also look at prostaglandin levels in infants who receive Tylenol (acetaminophen) to determine if acetaminophen could be used as a safe alternative to current medical therapy.

Institution
MUSC
Recruitment Contact
Matthew Halliday
843-819-3592
hallida@musc.edu

Parents' perceptions of NCU discharge and infant readiness in transitional care Save

Date Added
May 18th, 2015
PRO Number
Pro00042954
Researcher
Bethany Carlos
Keywords
Children's Health, Pediatrics
Summary

Parents who have infants in the MUSC NCU will be asked to give their opinions about the discharge process as their infants transition from receiving hospital care to being cared for at home. The parents will complete surveys and interviews to offer their feedback. The parents' opinions will be compared with the infant's unexpected readmission to the hospital after discharge, if it occurred. Parents will also decide what is most important for a successful discharge of the infant. The factors that parents consider to be most important will also be compared to which factors nurses find to be important.

Institution
MUSC
Recruitment Contact
Bethany Carlos
803-556-8332
carlosb@musc.edu

Validation of the Residual Lesion Score for Congenital Heart Surgery Save

Date Added
April 14th, 2015
PRO Number
Pro00042799
Researcher
Eric Graham
Keywords
Children's Health, Heart, Infant, Pediatrics, Surgery
Summary

This multi-center prospective study will validate the RLS as a tool to predict early and mid-term outcomes for five common congenital cardiac operations. The RLS study will develop the first validated tool for measurement of residual lesions following congenital heart surgery. The proposed project will also lay the groundwork for future projects, facilitating continuous quality improvement in congenital heart surgery.

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

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients Save

Date Added
April 7th, 2015
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered ?investigational? products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-2708
simonsjl@musc.edu

GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes Save

Date Added
April 7th, 2015
PRO Number
Pro00016329
Researcher
Andrew Atz
Keywords
Cardiovascular, Children's Health, Genetics, Heart, Pediatrics
Summary

Genetic Testing of neonates undergoing surgery for single ventricle cardiac defects (SVCD) and other congenital cardiac defects. DNA testing with an aim to identifying genetic factors that aid survival and recovery in SCD patients.

Genetic contribution to patient outcomes: Over the past two decades, there has been dramatic improvement in the survival and functional outcome of patients with all forms of congenital cardiac defects. Yet, there exists significant variability in outcomes that becomes more pronounced as the level of surgical intervention increases and the exposure to adverse hemodynamic conditions becomes more prolonged and more profound. This is particularly noticeable in the SCD patient group where there are continued high levels of mortality and levels of disability that can be quite severe. While these poor outcomes can on occasion be attributed to technical difficulties, complex cardiac anatomy or patient co-morbidities, more commonly they occur in patients that do not superficially appear to be any different than those that will ultimately have excellent outcomes. What is becoming increasingly apparent is that every patient differs in their ability to tolerate the challenges presented by the peri-operative environment. Therefore, significant improvements in outcomes may depend on identification of the genetic factors that place some patients at greater risk and designing treatment protocols to minimize those risks.

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

Early Power Mobility Study for Children with Neuromuscular Disorders Save

Date Added
March 18th, 2015
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

Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections (ABS01) Save

Date Added
March 18th, 2015
PRO Number
Pro00030944
Researcher
Andrew Atz
Keywords
Children's Health
Summary

The most commonly used drugs in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. The proposed study will provide the safety information required for labeling. In addition, the PK of the study drugs has been or will be characterized in premature infants under an IND mechanism.

Institution
MUSC
Recruitment Contact
Hibah Al Nasiri
843-792-7857
alnasiri@musc.edu

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