Abstract

BABY HUG is a randomized, double-blind, placebo-controlled trial to determine if hydroxyurea can prevent the onset of chronic end organ damage in young children with sickle cell anemia. BABY HUG follows the successful completion of two other sickle cell disease trials, the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) and the Pediatric Hydroxyurea (PED HUG) Trial. Approximately 200 children, ages six months to 24 months, with sickle cell disease will be recruited to receive either hydroxyurea or placebo. The children will be screened at trial start-up for signs of abnormal brain, renal, pulmonary, and splenic function, and for developmental milestones. They will then be randomly assigned to receive hydroxyurea or a placebo and followed with yearly studies of chronic end organ damage of the major organ systems.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Division of Blood Diseases And Resources (NHLBI)
Type
Research and Development Contracts (N01)
Project #
N01HB007160-001
Application #
6356152
Study Section
Project Start
2000-08-01
Project End
2006-07-31
Budget Start
2000-09-21
Budget End
2001-08-31
Support Year
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Clinical Trials and Surveys Corporation
Department
Type
DUNS #
City
Owings Mills
State
MD
Country
United States
Zip Code
21117

  Publications

Lederman, Howard M; Connolly, Margaret A; Kalpatthi, Ram et al. (2014) Immunologic effects of hydroxyurea in sickle cell anemia. Pediatrics 134:686-95
Rana, Sohail; Houston, Patricia E; Wang, Winfred C et al. (2014) Hydroxyurea and growth in young children with sickle cell disease. Pediatrics 134:465-72
Armstrong, F Daniel; Elkin, T David; Brown, R Clark et al. (2013) Developmental function in toddlers with sickle cell anemia. Pediatrics 131:e406-14
Lo, Joan C; Sinaiko, Alan; Chandra, Malini et al. (2013) Prehypertension and hypertension in community-based pediatric practice. Pediatrics 131:e415-24
Alvarez, Ofelia; Miller, Scott T; Wang, Winfred C et al. (2012) Effect of hydroxyurea treatment on renal function parameters: results from the multi-center placebo-controlled BABY HUG clinical trial for infants with sickle cell anemia. Pediatr Blood Cancer 59:668-74
McGann, Patrick T; Flanagan, Jonathan M; Howard, Thad A et al. (2012) Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG Phase III Clinical Trial. Pediatr Blood Cancer 59:254-7
Lebensburger, Jeffrey D; Miller, Scott T; Howard, Thomas H et al. (2012) Influence of severity of anemia on clinical findings in infants with sickle cell anemia: analyses from the BABY HUG study. Pediatr Blood Cancer 59:675-8
Miller, Scott T; Rey, Kathy; He, Jin et al. (2012) Massive accidental overdose of hydroxyurea in a young child with sickle cell anemia. Pediatr Blood Cancer 59:170-2
Thornburg, Courtney D; Files, Beatrice A; Luo, Zhaoyu et al. (2012) Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood 120:4304-10; quiz 4448
Wang, Winfred C; Ware, Russell E; Miller, Scott T et al. (2011) Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG). Lancet 377:1663-72

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