Identifying Barriers in Accessing Early Intervention Services in Underserved Populations Save

Date Added
April 20th, 2016
PRO Number
Pro00052588
Researcher
Michelle Gilbert
Keywords
Children's Health, Environmental Factors, Infant, Non-interventional, Pediatrics
Summary

One in six children has one or more developmental disabilities that affect speech, mobility, and learning. Early Intervention (EI) programs are beneficial in decreasing motor, cognitive, and social developments in infants and children diagnosed with developmental delays or disabilities. The purpose of this study is to identify reasons why children under the age of 3 with developmental delays or disabilities who are qualified to receive early intervention services are not receiving them. Provider and parent perceptions will be explored to determine barriers in accessing and obtaining these services.

Institution
MUSC
Recruitment Contact
Michelle Gilbert
646-359-1665
gilbert@musc.edu

Retrospective and Prospective Data Collection of Maternal, Fetal, and Neonatal Variables from Patients Referred to Fetal Heart Society Participant Centers with a Maternal or Fetal Abnormality Aff ecting the Fetal Cardiovascular System. (Fetal Heart Society Collaborative Research Database Project) FHS Protocol Number 001 Save

Date Added
April 18th, 2016
PRO Number
Pro00054603
Researcher
Carolyn Taylor
Keywords
Children's Health, Pregnancy
Summary

In the past, many patients have been referred to a FHS participant site for evaluation and treatment of maternal or fetal abnormalities. Until recently, most studies regarding maternal or fetal disease have been single-center studies. Many maternal and fetal abnormalities are exceedingly rare. Due to the relative rarity of many forms of fetal congenital malformations, little collective short- and long-term data on outcomes exist. The Fetal Heart Society aims to collect data on a large cohort of patients and improve best clinical practice and improve outcomes for rare diseases.

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

Validation of the Residual Lesion Score for Congenital Heart Surgery Save

Date Added
April 6th, 2016
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

GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes Save

Date Added
April 5th, 2016
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

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 5th, 2016
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
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

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

Date Added
March 22nd, 2016
PRO Number
Pro00053576
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 text messaging with a health care provider. Participants are needed to briefly review the intervention and provide feedback.

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

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

Date Added
February 18th, 2016
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

A Randomized Clinical Trial Comparing The Overall Adverse Event Rate Of Inguinal Hernia (IH) Repair Prior To NICU Discharge Versus IH Repair After NICU Discharge And Beyond 55 Weeks Post Conceptual Age In Premature Infants. Save

Date Added
February 16th, 2016
PRO Number
Pro00041985
Researcher
Aaron Lesher
Keywords
Children's Health, Surgery
Summary

The Hernia in Premies (HIP) Trial is a multi-site randomized clinical trial that is comparing two accepted treatment choices, surgery before or after neonatal intensive care unit (NICU) discharge, for inguinal hernia (IH) repair in premature infants. The reason we are doing this study is that surgeons and neonatologists currently do not know the best time to perform the hernia repair. Some providers recommend having the hernia fixed before discharge from the neonatal intensive care unit (NICU) and some believe waiting until after NICU discharge is better. Both treatments are standard options for IH repair in premature infants. Also, all babies that have IH repair receive anesthesia. We also do not know if the age of the child receiving anesthesia affects neurodevelopment. We are comparing the timing of anesthesia exposure between the two treatments (IH repair before or after NICU discharge) to help answer these questions.

By volunteering to take part in the HIP Trial, your child will be randomly assigned to have the operation before or after NICU discharge. This means that the timing of the repair operation will be determined by chance, like flipping a coin, and he/she has an equal chance of being treated before or after NICU discharge. We will be collecting information about your baby and the treatment that he or she receives, and how your baby recovers before and after the surgery. We will also collect information about your baby from clinic notes and results from your baby?s routine 2 year follow-up neurodevelopmental testing, where your child will be asked questions that measure cognitive, language, social and motor development. We will stop collecting information about your baby and your participation will end when your child is 2 years old. There are no extra medical tests or blood work being done for research purposes in the HIP trial.

Institution
MUSC
Recruitment Contact
Aaron Lesher
843-792-3853
leshera@musc.edu

Efficacy of Surgery in Treating Children with Idiopathic Constipation who are "Refractory to Medical Management" Save

Date Added
February 3rd, 2016
PRO Number
Pro00042654
Researcher
James Glasser
Keywords
Autism, Children's Health, Digestive System, Nutrition, Pain, Surgery
Summary

There are three operations that can be offered to children with idiopathic constipation refractory to medical management:
1. insertion of a tube into the cecum or the appendix for antegrade enemas.
2. removal of the sigmoid colon (if it is redundant).
3. removal of the rectum and sigmoid colon, if they are grossly dilated.
The later two options are difficult operations that carry the risk of an anastomotic leak that may be life threatening. Is it justified to assume this risk in treating a benign disease?

Institution
Palmetto
Recruitment Contact
Martin Durkin
803-434-6963
martin.durkin@palmettohealth.org

Gendered Racial Factors in Girls? Self-Regulation, Drug, and Behavior Disparities Save

Date Added
February 2nd, 2016
PRO Number
Pro00051830
Researcher
Colleen Hallidayboykins
Keywords
Adolescents, Children's Health, Education, Healthy Volunteer Studies, Mental Health, Minorities, Substance Use, Women's Health
Summary

The purpose of this study is to understand factors contributing to managing emotions, behavior problems, and substance use among girls. Middle school adolescent girls will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use. Their reactions to recent incidents of unfair treatment or disciplinary action will also be assessed.

Institution
MUSC
Recruitment Contact
Jennifer Powell
843-876-0567
smithjl@musc.edu

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