N/A N=163

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

Anemia, Sickle Cell

Bottom Line

View on ClinicalTrials.gov: NCT00890396 ↗

Enrolled (actual)

163

Serious AEs

1.2%

Results posted

Aug 2020

Primary outcome: Primary: Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo — 16; 15; 44; 34 Participants — p=0.67

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Hydroxyurea (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo	16; 15; 44; 34	0.67
PRIMARY Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit	26; 5; 62; 13	>0.99
PRIMARY Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo	-1.55; -1.40	0.78
PRIMARY Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo	-1.55; -1.40	0.78
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	-1.30; -1.70	0.11
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	-1.30; -1.70	0.11
PRIMARY Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo	1847.50; 1906.50	0.95
PRIMARY Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo	1847.50; 1906.50	0.95
PRIMARY Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit	1661.00; 1510.00	0.40
PRIMARY Change in Howell-Jolly Bodies From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit	1972.00; 1500.50	0.11

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00890396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.