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

Evaluation of ACCU-CHEK® Inform II System for Testing Arterial, Venous and Neonatal Heel Stick Samples in Critically Ill Patients Save

Date Added
September 26th, 2017
PRO Number
Pro00068789
Researcher
Gary Headden
Keywords
Diabetes, Infant, Non-interventional
Summary

The ACCU-CHEK Inform II is an FDA Food and Drug Administration) approved meter for checking blood glucose levels. This study is to gain FDA approval for use in critical care settings such as Intensive Care Units and Emergency Departments.

Institution
MUSC
Recruitment Contact
Robert Houck
843-792-3576
houckr@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
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

Developmental Impact of NICU Exposures (DINE) UG3 Study Environmental Influences on Child Health Outcomes (ECHO) Program Save

Date Added
May 2nd, 2017
PRO Number
Pro00065251
Researcher
Carol Wagner
Keywords
Children's Health, Infant
Summary

This study is a longitudinal, observational follow-up of MUSC subjects previously enrolled in the NIH funded Tolsurf study. It is being conducted to determine the developmental impact of NICU exposures to chemical plasticizers called phthalates that are found in the NICU environment. Subjects who participated in the Tolsurf study are part of a larger group of NIH funded studies. Participants in each of these NIH funded NICU studies have urine samples from their NICU stay stored in a biobank. These urine samples will be tested for phthalates. If the families agree to let their children participate in the study, results of pulmonary testing and developmental testing will be compared to levels of phthalates in the urine collected during their NICU stay. Previous studies have linked phthalates in-utero to developmental delays, asthma, and altered onset of puberty. The aims of the DINE study are to identify the sources of phthalates in the NICU and measure the impact of phthalates in the NICU.

Institution
MUSC
Recruitment Contact
Lynn Smith
(843)324-8442
smithlt@musc.edu

South Carolina Sickle Cell Disease Access to Care Pilot Program (SC) Save

Date Added
July 19th, 2016
PRO Number
Pro00054236
Researcher
Julie Kanter washko
Keywords
Adolescents, Blood Disorders, Children's Health, Infant
Summary

The purpose of this research protocol is to collect information about individuals living with sickle cell disease to help improve the care of those patients. We hope to understand more about the disease itself, the best ways to treat the disease, and the best ways to help patients with sickle cell disease get care. The goal is to have clinical information about every person diagnosed with sickle cell disease in South Carolina so that we can better treat the disease and help develop new ways to improve outcomes.

Institution
MUSC
Recruitment Contact
Katherine Williams-Turner
843-876-0821
willkat@musc.edu

National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease Save

Date Added
June 23rd, 2016
PRO Number
Pro00056522
Researcher
Frances Woodard
Keywords
Cardiovascular, Children's Health, Heart, Infant, Non-interventional
Summary

Transforming health care and outcomes for children with rare diseases is difficult within the current health care system. There is great variation in care delivery, inadequate and slow application of existing evidence, and ineffective use of available data to generate new knowledge. Individual care centers have inadequate numbers of patients for robust learning and improvement. In order to redesign the system, changes must take place at multiple levels, including the patient and family, clinician, practice and the network. The purpose of this project is to design, develop, and test further refinements to an improvement and research network focused on HLHS, the most severe congenital heart defect, and to use a registry to simultaneously improve clinical care, redesign care delivery systems and to conduct quality improvement, health services, outcomes, and comparative effectiveness research. The purpose of this initiative, specifically, is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes. We utilize a quality improvement methodology, known as the adapted learning collaborative model, which expedites the implementation of tools and strategies that facilitate changes such as systematic care coordination, cardiovascular monitoring, and nutritional monitoring into every day practice. The NPC-QIC registry is used to document the impact of these changes on various care processes and outcomes (e.g., mortality rate, readmissions, and weight gain).

Institution
MUSC
Recruitment Contact
Frances Woodard
843-792-3292
klinefl@musc.edu

A Phase Ib/IIa Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates Save

Date Added
April 26th, 2016
PRO Number
Pro00048200
Researcher
Sarah Taylor
Keywords
Bowel, Digestive System, Disease Prevention, Infant, Nutrition, Pediatrics
Summary

The Sponsor is conducting a clinical study with STP206 for the prevention of Necrotizing Enterocolitis (NEC) in preterm infants weighing less than 4.4 lbs. (2000g). NEC is the most common serious disease of the gut in preterm infants. The purpose of this study is to look at the safety of STP206 in babies born early, and to get early information on whether STP206 may prevent NEC.

STP206 is an investigational product, meaning it is not yet approved by the US Food and Drug Administration for use in the United States. STP206 contains live bacteria and is considered a Live Biotherapeutic. The two types of bacteria are Lactobacillus and Bifidobacteria. These bacteria are used in foods such as cheese, yogurt, sauerkraut, and pickles, and have been consumed safely for years and are commonly contained in probiotic products that are currently sold throughout the world. These bacteria also are normally present in parts of the body such as bowel, mouth, skin, and the vagina. These bacteria generally do not cause disease. There have been studies of probiotic bacteria in premature babies that suggest these types of bacteria are effective in preventing NEC. The purpose of this study is to determine the safety of STP206 and if it is effective in preventing NEC.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
792-0601
yeadon@musc.edu

Analysis of genetic variant and treatment based variations in infants at risk for retinopathy of prematurity (ROP) Save

Date Added
July 31st, 2015
PRO Number
Pro00041164
Researcher
Lakshmi Katikaneni
Keywords
Children's Health, Genetics, Infant, Vision/ Eye
Summary

Infants born early who are in the neonatal intensive care unit will be included if they meet national guidelines for retinopathy of prematurity (ROP) screening exams. Informed consent will be given to the parent(s) or legal guardians. 1.5-2 ml of blood will be drawn from a vein when the child is enrolled in the study and may be drawn again if the child requires treatment of eye disease. A cheek swab will also be obtained. These biologic samples will be shipped overnight to the University of Utah for genetic analysis. Analysis will determine if a change in gene expression causes retinopathy of prematurity. Infants enrolled in the study will be followed clinically per established ROP screening guidelines. They will not require additional study exams.

Institution
MUSC
Recruitment Contact
Kinsey Shirer
843-792-2799
evanssa@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

N-Acetylcysteine (NAC) and Vitamin-D in Hypoxic-Ischemic Newborns Treated with Hypothermia Save

Date Added
February 4th, 2014
PRO Number
Pro00031254
Researcher
Dorothea Jenkins
Keywords
Infant, Nervous System, Pediatrics, Stroke, Vitamin D
Summary

We propose to conduct a 1-year, two-center, open-label, non-randomized pilot trial to evaluate the disposition and safety of NAC in combination with Vitamin D in neonates who present within 6 hrs of hypoxia ischemia/asphyxial event and are receiving moderate hypothermia to 33 degrees C for 72 hours per standard protocol.

Institution
MUSC
Recruitment Contact
Kathryn Hope
843-792-2112
hopek@musc.edu

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