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

COLLABORATIVE LEARNING PROJECT OF PERIOPERATIVE CARE OF INFANTS WITH CONGENITAL HEART DISEASE Save

Date Added
March 18th, 2015
PRO Number
Pro00031239
Researcher
Mark Scheurer
Keywords
Children's Health
Summary

To determine whether a collaborative learning-derived Clinical Practice guideline (CPG) for early postoperative ventilation and extubation results in a higher proportion of subjects extubated early after infant heart surgery. This will be tested in 5 Pediatric Heart Network (PHN) sites. A comparison will be made to 5 other PHN sites who will not undergo specific training in the CPG. Times until extubation after 2 surgeries (tetraoligy of Fallot repair and repair of coarctation of aorta) will be compared between the 5 sites with active CPG learning vs. the 5 control sites. MUSC is being asked to be a control site.

Institution
MUSC
Recruitment Contact
Harvey Frampton
843-792-7857
frampton@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
March 17th, 2015
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

South Carolina Children's Educational Surveillance Study Save

Date Added
March 3rd, 2015
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

A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension Save

Date Added
January 13th, 2015
PRO Number
Pro00039004
Researcher
Melissa Henshaw
Keywords
Adolescents, Children's Health, Hypertension/ High Blood Pressure, Pediatrics
Summary

This research study is for children between 6 years and 18 years of age who have been diagnosed with hypertension, or high blood pressure. Hypertension or high blood pressure is when someone?s blood vessels, called arteries, tighten too much. The study lasts 12 months and could involve up to 17 study visits. Compensation is available.

The main purpose of this study is to find out if the study drug, Azilsartan medoxomil (also called AZM, TAK-491, or AR14) is effective in controlling blood pressure in children 6 to less than 18 years of age and to find out if it is safe and well tolerated in this age group compared to placebo. The safety and effectiveness of AZM in children less than 18 years of age have not yet been established and currently are under investigation in the age group 1 to 17 years. This means it does not currently have FDA approval for use in children and adolescents.

Another purpose of the study is to compare a drug called losartan potassium (Cozaar) to AZM. Cozaar is an FDA approved drug that is used to treat high blood pressure in adults and children

Institution
MUSC
Recruitment Contact
Anna Patton
843-792-9454
tecklenb@musc.edu

Pharmacokinetics of Multiple Dose Methadone in Children Save

Date Added
December 2nd, 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 2nd, 2014
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

CureGN: Cure Glomerulonephropathy Network Save

Date Added
December 2nd, 2014
PRO Number
Pro00038759
Researcher
Katherine Twombley
Keywords
Adolescents, Children's Health, Disease Prevention, Kidney, Minorities, Pediatrics, Transplant, Vaccine
Summary

Adult and Pediatric patients with glomerular disease:
Patients of all ages are needed to participate in a research study to investigate glomerular disease and create a worldwide database to help in the research and future treatment of this disease. To join this study, you must have a type of glomerular disease, have had a first kidney biopsy within the last 5 years, not be on dialysis, or not have had a kidney transplant.

The study is projected to last 4 years, and all study procedures will be done at regular clinic visits (between 1 and 3 yearly). Study procedures include filling out questionnaires and a blood draw at each visit.

Compensation is available for study participation.

Institution
MUSC
Recruitment Contact
Anna Patton
843-792-9454
tecklenb@musc.edu

Ketamine in Chronic Kid?s Pain Save

Date Added
November 4th, 2014
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

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

Date Added
October 23rd, 2014
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
kim Cantrell
864-809-2875
mcantrell@srhs.com

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