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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01783990
Other study ID # HHSN268201200023C
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date December 31, 2016

Study information

Verified date September 2016
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 24 Months to 18 Years
Eligibility Inclusion Criteria:

- All subjects enrolled in the BABY HUG Follow-Up I Study who participated for at least 24 months are eligible for the Follow-Up Study II

Exclusion Criteria:

- Subjects that have received a Stem Cell Transplant are not eligible for enrollment

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Emory University School of Medicine Atlanta Georgia
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Sinai Hospital of Baltimore Alfred I Coplan Pediatric Hematology Oncology Outpatient Center Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Downstate Medical Center Brooklyn New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Children's Hospital of Michigan/Wayne State University Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States University of Mississippi Medical Center Jackson Mississippi
United States St. Jude Children's Research Hospital Memphis Tennessee
United States University of Miami School of Medicine Miami Florida
United States Children's National Medical Center Center for Cancer and Blood Disorders Washington District of Columbia
United States Howard University College of Medicine Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between the randomized treatment groups (hydroxyurea vs placebo). The change in splenic function from baseline (before treatment initiation) to age 10 years (a visit when child turned 10 years old) was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased. baseline and when child turned 10 years old
Primary Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. The change in splenic function from baseline (before treatment initiation) to age 10 years (a visit when child turned 10 years old) was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased. baseline and when child turned 10 years old
Primary Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo The change in the percentage of pitted cell from randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between the randomized treatment groups (hydroxyurea vs placebo). Baseline and End of follow-up II study (up to 13 years from randomization date)
Primary Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit The change in the percentage of pitted cell from the randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. Baseline and End of follow-up II study (up to 13 years from randomization date)
Primary Change in Howell Jolly Body (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo The change in Howell Jolly Body from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell Jolly Body was compared between the randomized treatment groups (hydroxyurea vs placebo). Baseline and End of follow-up II study (up to 13 years from randomization date)
Primary Change in Howell Jolly Body (HJB) Count From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea The change in Howell Jolly Body count from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. Baseline and End of follow-up II study (up to 13 years from randomization date)
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