At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
Hydroxyureadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
National Heart, Lung, and Blood Institute (NHLBI)·observational·Posted Feb 5, 2013·Updated Aug 20, 2020
In Brief
An observational study evaluating Hydroxyurea for Sickle Cell Anemia. Completed, enrolled 150 participants across 14 sites.
Detailed 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 Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Anemia
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedFeb 2013
Primary CompletionDec 2016
TodayJul 2026
First PostedFeb 5, 2013
Enrollment StartOct 1, 2012
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.4 years ago
Interventions
Hydroxyureadrug
Parents and child's doctor may plan to use or not to use hydroxyurea.