Hydroxyurea and growth in young children with sickle cell disease.
Author(s): Rana S(1), Houston PE(2), Wang WC(3), Iyer RV(4), Goldsmith J(5), Casella JF(6),
Reed CK(2), Rogers ZR(7), Waclawiw MA(5), Thompson B(8); BABY HUG Investigators.
Affiliation(s): Author information:
(1)Department of Pediatrics and Child Health, Howard University, Washington,
District of Columbia; srana@howard.edu.
(2)Department of Pediatrics and Child Health, Howard University, Washington,
District of Columbia;
(3)St. Jude Children's Research Hospital, Memphis, Tennessee;
(4)University of Mississippi Medical Center, Jackson, Mississippi;
(5)National Heart, Lung, and Blood Institute, Bethesda, Maryland;
(6)Division of Hematology, Department of Pediatrics, Johns Hopkins University,
Baltimore, Maryland;
(7)UT Southwestern Medical Center, Dallas, Texas; and.
(8)Clinical Trials & Surveys Corporation, Owings Mills, Maryland.
Publication date & source: 2014, Pediatrics. , 134(3):465-72
BACKGROUND: Growth impairment is a known complication of sickle cell disease.
Effects of hydroxyurea (HU) on growth in very young children are not known.
METHODS: Height, weight, BMI, and head circumference (HC) were compared with
World Health Organization (WHO) standards in BABY HUG, a multicenter, randomized,
double-blinded, placebo-controlled 2-year clinical trial of HU in 193 children 9
to 18 months of age. Anthropometric data were closely monitored and converted to
z scores by using WHO standardized algorithms for descriptive analyses. The
treatment and placebo groups were compared longitudinally by using a mixed model
analysis.
RESULTS: At entry, the z scores of BABY HUG children were higher than WHO norms.
After 2 years of HU or placebo treatment, there were no significant differences
between the groups, except for the mean HC z scores at study exit (HU: +0.8
versus placebo: +1.0, P = .05). Baseline z scores were the best predictors of z
scores at study exit. The absolute neutrophil count, absolute reticulocyte count,
and total white blood cell count had significant negative correlations with
growth measures.
CONCLUSIONS: Both groups had normal or near normal anthropometric measures during
the study. The HC z scores at study entry and exit were slightly greater than WHO
norms. Higher baseline white blood cell count, absolute reticulocyte count, and
absolute neutrophil count were associated with poorer growth. The significance of
the slightly lower HC in the treatment group at study exit is not clear. Trends
toward normalization of weight and height and effects on HC will be monitored in
ongoing BABY HUG follow-up studies.
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