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 #
N01HB007155-001
Application #
6360207
Study Section
Project Start
2000-09-01
Project End
2006-07-31
Budget Start
2000-09-29
Budget End
2001-08-03
Support Year
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
St. Jude Children's Research Hospital
Department
Type
DUNS #
067717892
City
Memphis
State
TN
Country
United States
Zip Code
38105

  Publications

Kalpatthi, Ram; Thompson, Bruce; Lu, Ming et al. (2013) Comparison of hematologic measurements between local and central laboratories: data from the BABY HUG trial. Clin Biochem 46:278-81
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
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
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
McCarville, M Beth; Luo, Zhaoyu; Huang, Xiangke et al. (2011) Abdominal ultrasound with scintigraphic and clinical correlates in infants with sickle cell anemia: baseline data from the BABY HUG trial. AJR Am J Roentgenol 196:1399-404
McGann, Patrick T; Ware, Russell E (2011) Hydroxyurea for sickle cell anemia: what have we learned and what questions still remain? Curr Opin Hematol 18:158-65
Heeney, Matthew M; Ware, Russell E (2010) Hydroxyurea for children with sickle cell disease. Hematol Oncol Clin North Am 24:199-214
Thornburg, Courtney D; Rogers, Zora R; Jeng, Michael R et al. (2010) Adherence to study medication and visits: data from the BABY HUG trial. Pediatr Blood Cancer 54:260-4
Ware, Russell E (2010) How I use hydroxyurea to treat young patients with sickle cell anemia. Blood 115:5300-11

Showing the most recent 10 out of 13 publications