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

April 27, 2009
July 24, 2009
September 2008
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00890396 on ClinicalTrials.gov Archive Site
Evaluation of initial BABY HUG study treatment assignment [ Time Frame: Measured in Year 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Study

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Stored blood and urine

Non-Probability Sample

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

Anemia, Sickle Cell
Not Provided
  • 1
    Participants in the active follow-up group.
  • 2
    Participants in the passive follow-up group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
167
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00890396
647, N01 HB07160
Yes
Bruce Thompson, PhD, PI, Clinical Trials and Surveys Corp. (C-TASC)
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Bruce Thompson, PhD Clinical Trials & Surveys Corp (C-TASC)
National Heart, Lung, and Blood Institute (NHLBI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP