Influence of severity of anemia on clinical findings in infants with sickle cell
anemia: analyses from the BABY HUG study.
Author(s): Lebensburger JD, Miller ST, Howard TH, Casella JF, Brown RC, Lu M, Iyer RV,
Sarnaik S, Rogers ZR, Wang WC; BABY HUG Investigators.
Affiliation(s): University of Alabama at Birmingham, Birmingham, Alabama, USA.
jlebensburger@peds.uab.edu
Publication date & source: 2012, Pediatr Blood Cancer. , 59(4):675-8
BACKGROUND: Clinical complications of sickle cell anemia begin in infancy. BABY
HUG (ClinicalTrials.gov, NCT00006400) was a NHLBI-NICHD supported randomized
phase III placebo-controlled trial of hydroxyurea (HU) in infants (recruited at
9-18 months) unselected for clinical severity with sickle cell anemia. This
secondary analysis of data from BABY HUG examines the influence of anemia on the
incidence of sickle cell related complications, and the impact of hydroxyurea
therapy in altering these events by comparing children with lower (<25th
percentile) and higher (>75th percentile) hemoglobin concentrations at study
entry.
PROCEDURE: Infants were categorized by: (1) age-adjusted hemoglobin quartiles as
determined by higher (Hi) and lower (Lo) hemoglobin concentrations at study entry
(9-12 months old: <8.0 and >10.0 gm/dL; 12-18 months old: <8.1 and >9.9 gm/dL)
and (2) treatment arm (hydroxyurea or placebo). Four subgroups were created:
placebo (PL) LoHb (n = 25), PL HiHb (n = 27), hydroxyurea (HU) LoHb (n = 21), and
HU HiHb (n = 18). The primary and secondary endpoints of BABY HUG were analyzed
by subgroup.
RESULTS: Infants with lower hemoglobin at baseline were more likely to have a
higher incidence of clinical events (acute chest syndrome, pain crisis, fever) as
well as higher TCD velocities and lower neuropsychological scores at study exit.
Hydroxyurea reduced the incidence of these findings.
CONCLUSION: Infants with more severe anemia are at risk for increased clinical
events that may be prevented by early initiation of hydroxyurea.
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