Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol

Clinical Trial
Study Details
Enrollment
150
Interventions
Description

Parents and child's doctor may plan to use or not to use hydroxyurea.

Name
Hydroxyurea
Type
Drug
Phase
N/A
Status
COMPLETED
Study ID #
NCT01783990
Study Type
Observational
Summary

The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also called HU) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung disease, stroke, and blood infection.

Study Overview
Conditions
Description

The current observational trial, Follow-Up Study ((FUS) II includes enhanced neuropsychological, brain, cardiac, and pulmonary evaluations for this very well characterized cohort of subjects. Measures of spleen and renal function and markers of DNA damage will continue to be collected. Assessment of other target organs in sickle cell disease including pulmonary and cardiac function will be performed in addition to evaluation of developmental aspects of sickle cell disease (SCD) and potential HU toxicity.

Contacts and Locations
Locations
Facility

University of Alabama at Birmingham
Birmingham, Alabama 35233
United States

GeoPoint
33.52066, -86.80249
Facility

Children's National Medical Center Center for Cancer and Blood Disorders
Washington D.C., District of Columbia 20010
United States

GeoPoint
38.89511, -77.03637
Facility

Howard University College of Medicine
Washington D.C., District of Columbia 20060
United States

GeoPoint
38.89511, -77.03637
Facility

University of Miami School of Medicine
Miami, Florida 33136
United States

GeoPoint
25.77427, -80.19366
Facility

Emory University School of Medicine
Atlanta, Georgia 30342
United States

GeoPoint
33.749, -84.38798
Facility

Johns Hopkins University School of Medicine
Baltimore, Maryland 21205
United States

GeoPoint
39.29038, -76.61219
Facility

Sinai Hospital of Baltimore Alfred I Coplan Pediatric Hematology Oncology Outpatient Center
Baltimore, Maryland 21215
United States

GeoPoint
39.29038, -76.61219
Facility

Children's Hospital of Michigan/Wayne State University
Detroit, Michigan 48201
United States

GeoPoint
42.33143, -83.04575
Facility

University of Mississippi Medical Center
Jackson, Mississippi 39216
United States

GeoPoint
32.29876, -90.18481
Facility

Downstate Medical Center
Brooklyn, New York 11203
United States

GeoPoint
40.6501, -73.94958
Facility

Duke University Medical Center
Durham, North Carolina 27710
United States

GeoPoint
35.99403, -78.89862
Facility

Medical University of South Carolina
Charleston, South Carolina 29425
United States

GeoPoint
32.77632, -79.93275
Facility

St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United States

GeoPoint
35.14953, -90.04898
Facility

University of Texas Southwestern Medical Center at Dallas
Dallas, Texas 75390
United States

GeoPoint
32.78306, -96.80667