Trial record 2 of 7 for:    BABY HUG

Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00890396
First received: April 27, 2009
Last updated: July 24, 2009
Last verified: July 2009
  Purpose

Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with SCA. The purpose of this follow-up study is to evaluate the long-term effects of hydroxyurea in children who have participated in the BABY HUG study.


Condition Phase
Anemia, Sickle Cell
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Study

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Comparison of the proportion of infants with decreased or absent spleen function [ Time Frame: Measured at Years 2 and 4 (or at the end of the study, whichever comes first) ] [ Designated as safety issue: Yes ]
  • Comparison of kidney damage, as measured by glomerular filtration rate (GFR) [ Time Frame: Measured at Years 2 and 4 (or at the end of the study, whichever comes first) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of initial BABY HUG study treatment assignment [ Time Frame: Measured in Year 1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stored blood and urine


Estimated Enrollment: 167
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Participants in the active follow-up group.
2
Participants in the passive follow-up group.

Detailed Description:

SCA is an inherited blood disorder in which the body makes sickle-shaped red blood cells that contain abnormal hemoglobin. The sickled cells block blood flow in the vessels that lead to limbs and organs. This can cause pain, serious infections, and organ damage. The BABY HUG study (NCT00006400) is examining whether the medication hydroxyurea can prevent organ damage, especially in the spleen and kidneys, in children with SCA. This study is a follow-up study to the BABY HUG study and will enroll children who have participated in the BABY HUG study. The purpose of this study is to examine the long-term effects of using hydroxyurea as a treatment for SCA, including both the risks and benefits. Study researchers will also investigate the optimal age to begin treatment with hydroxyurea in children with SCA.

This study will enroll children between 2 and 7 years old who participated in the BABY HUG study. Hydroxyurea will not be provided to participants as part of this study, but participants may receive the medication from their own doctors. Parents of participants can choose for their child to participate in this study in one of two ways—by enrolling in either a passive follow-up group or an active follow-up group. For participants in the passive follow-up group, study researchers will review participants' medical records every 6 months, in addition to reviewing brain ultrasound tests and computed tomography (CT) or magnetic resonance imaging (MRI) scans, if completed. Participants will have a blood and urine collection at baseline and Year 4 (or at the end of the study, whichever comes first). Participants in the active follow-up group will take part in the same study procedures as participants in the passive follow-up group. In addition, at Year 2, participants in this group will undergo an additional blood and urine collection, a scanning procedure to obtain images of the liver and spleen, a kidney test, neuropsychological testing, and an ultrasound imaging test to evaluate liver and spleen size.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children from the initial BABY HUG study who agree to participate in this follow-up study.

Criteria

Inclusion Criteria:

  • All children who completed at least 18 months of follow-up visits in the initial BABY HUG study
  • Children from the initial BABY HUG study who are on a chronic transfusion program or who are recipients of a bone marrow transplant

Exclusion Criteria:

  • Any child who was not enrolled in the initial BABY HUG study for at least 18 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890396

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Howard University College of Medicine
Washington, District of Columbia, United States, 20060
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30342
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Michigan
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New York
Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Investigators
Principal Investigator: Bruce Thompson, PhD Clinical Trials & Surveys Corp (C-TASC)
  More Information

Additional Information:
No publications provided

Responsible Party: Bruce Thompson, PhD, PI, Clinical Trials and Surveys Corp. (C-TASC)
ClinicalTrials.gov Identifier: NCT00890396     History of Changes
Other Study ID Numbers: 647, N01 HB07160
Study First Received: April 27, 2009
Last Updated: July 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Sickle Cell Anemia
Hydroxyurea

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 13, 2014