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

Date Added
May 7th, 2018
PRO Number
Pro00077156
Researcher
Lisa Knight
Keywords
Children's Health, Infant, 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
Palmetto
Recruitment Contact
Sarah Newman-Norlund
803-216-3377
Sarah.Newman-Norlund@uscmed.sc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF DUPILUMAB ADMINISTERED CONCOMITANTLY WITH TOPICAL CORTICOSTEROIDS IN PATIENTS, ?6 YEARS TO <12 YEARS OF AGE, WITH SEVERE ATOPIC DERMATITIS Save

Date Added
April 10th, 2018
PRO Number
Pro00075600
Researcher
Lara Wine lee

Silhouette
Keywords
Children's Health, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called dupilumab (given by injection) with corticosteroids is safe and effective in children with severe atopic dermatitis. Participation in the study will take about 13 visits to the clinic and 9 phone calls over a period of about 33 weeks.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
dermresearch@musc.edu

Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest
Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

Silhouette
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Effectiveness of continuous nebulization treatment of bronchodilation in patient admitted to PICU diagnosed with acute bronchiolitis Save

Date Added
February 15th, 2018
PRO Number
Pro00073193
Researcher
Sami Rishmawi
Keywords
Children's Health, Infant
Summary

Bronchiolitis is broadly defined as a clinical syndrome that occurs in children < 2 years of age and is characterized by upper respiratory symptoms followed by lower respiratory infection with inflammation, which results in wheezing and or crackles (rales). Bronchiolitis typically is caused by viruses. In ICU setting, the standard therapy of patient presents with acute bronchiolitis are bronchodilation medications. Recent recommendations of American Academy of Pediatrics stated that no evidence to support usage of any of bronchodilators,The goal of this study is validate the effectiveness of bronchodilators medications.

Institution
Spartanburg
Recruitment Contact
Sami Rishmawi
8642371109
srishmawi@srhs.com

Environmental Influences on Child Health Outcomes (ECHO) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Study Save

Date Added
October 31st, 2017
PRO Number
Pro00070764
Researcher
John Vena

Silhouette
Keywords
Children's Health, Obesity
Summary

We will recruit mother-child pairs for participation in the study and both the mother and child will be considered study participants. However, in cases where it is not possible to recruit the mother, but the child is available to be in the study we will recruit the child with their parent or legal guardian providing consent for the child's participation in the study

Institution
MUSC
Recruitment Contact
JacKetta Cobbs
843-792-0450
echo-nfgs@musc.edu

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

Silhouette
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

A Family-Centered Self-Management Program for Young Children with Sickle Cell Disease: Phase II Save

Date Added
September 7th, 2017
PRO Number
Pro00068250
Researcher
Shannon Hudson

Silhouette
Keywords
Blood Disorders, Children's Health, Infant, Pediatrics
Summary

This study tests an intervention to help children with sickle cell disease ages 0-7 years and their families. The intervention is available on a smartphone or tablet, and includes an app for keeping track of symptoms and messaging with a health care provider. For more information, please contact Shannon at 843-792-9379.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

Self-Management for Families and Youth Living with Sickle Cell Disease - SMYLS Save

Date Added
September 2nd, 2017
PRO Number
Pro00062837
Researcher
Shannon Hudson

Silhouette
Keywords
Blood Disorders, Children's Health, Pediatrics
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile device over a 12-week period is helpful in managing symptoms of Sickle Cell Disease in children, such as pain and fatigue and quality of life. For more information, please contact Shannon at 843-792-9379.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

The effect of povidone-iodine ophthalmic surgical prep solution on respiration in children undergoing strabismus surgery with general anesthesia. Save

Date Added
August 15th, 2017
PRO Number
Pro00067331
Researcher
Michelle Rovner

Silhouette
Keywords
Children's Health, Pediatrics
Summary

This study is being done to study the effect of putting povidone-iodine ophthalmic or balanced saline solutions in the eye has on respirations during strabismus (eye alignment) surgery. Both of these solutions are FDA approved for use in this manner and will be done after patients are under anesthesia. The solution to be used is determined by randomization upon enrollment and will either be 3 drops of povidone-iodine ophthalmic solution in each eye (Group A) or 3 drops of BSS in each eye (Group B). The eye solution intervention period will take less than 5 minutes and will cause either only a slight delay or no delay in the surgical time. The only other intervention is the collection of data after induction (but just prior to IV insertion), as well as before and after the drops of eye solution are delivered.

Institution
MUSC
Recruitment Contact
Wanda Jones
8437921869
joneswr@musc.edu

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