This trial is active, not recruiting.

Condition sickle cell anemia
Treatment hydroxyurea
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborator National Institutes of Health (NIH)
Start date October 2012
End date December 2016
Trial size 158 participants
Trial identifier NCT01783990, HHSN268201200023C


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Blood and urine specimens, and questionnaires related to the child's health status. Liver Spleen Scan Abdominal Ultrasound Brain MRI/MRA Cardiac Echocardiogram/Pulmonary Function Testing Transcranial Doppler Neuropsychology Testing (Vineland, WISC-IV, Connor CPT II and Peds QOL)
hydroxyurea HU
Active and Passive groups both are on HU.
Information from usual clinical care of sickle cell disease. We will collect information from routine tests ordered by the child's clinical sickle cell doctors.
hydroxyurea HU
Active and Passive groups both are on HU.

Primary Outcomes

The primary objective of Follow-Up Study II is to monitor the continued safety and potential efficacy of HU treatment.
time frame: Every 6 months

Eligibility Criteria

Male or female participants from 24 months up to 18 years old.

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

Additional Information

Official title Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Principal investigator Susan Assmann, PhD
Description The current observational trial, Follow-Up Study II (designated 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 SCD and potential HU toxicity.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).