| Influence of severity of anemia on clinical findings in infants with sickle cell anemia: analyses from the BABY HUG study. | |
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MedLine Citation:
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PMID: 22190441 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Jeffrey D Lebensburger; Scott T Miller; Thomas H Howard; James F Casella; R Clark Brown; Ming Lu; Rathi V Iyer; Sharada Sarnaik; Zora R Rogers; Winfred C Wang; |
Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2011-12-20 |
Journal Detail:
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Title: Pediatric blood & cancer Volume: 59 ISSN: 1545-5017 ISO Abbreviation: Pediatr Blood Cancer Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-08-13 Completed Date: 2012-10-15 Revised Date: 2013-04-16 |
Medline Journal Info:
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Nlm Unique ID: 101186624 Medline TA: Pediatr Blood Cancer Country: United States |
Other Details:
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Languages: eng Pagination: 675-8 Citation Subset: IM |
Copyright Information:
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Copyright © 2011 Wiley Periodicals, Inc. |
Affiliation:
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University of Alabama at Birmingham, Birmingham, Alabama, USA. jlebensburger@peds.uab.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acute Disease Anemia, Sickle Cell / blood, complications*, drug therapy, physiopathology Antisickling Agents / therapeutic use Double-Blind Method Fever / etiology Hemoglobins / analysis Humans Hydroxyurea / therapeutic use Infant Kidney / physiopathology Pain / etiology Spleen / physiopathology Thoracic Diseases / etiology |
| Grant Support | |
ID/Acronym/Agency:
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N01-HB-07150/HB/NHLBI NIH HHS; N01-HB-07151/HB/NHLBI NIH HHS; N01-HB-07152/HB/NHLBI NIH HHS; N01-HB-07153/HB/NHLBI NIH HHS; N01-HB-07154/HB/NHLBI NIH HHS; N01-HB-07155/HB/NHLBI NIH HHS; N01-HB-07156/HB/NHLBI NIH HHS; N01-HB-07157/HB/NHLBI NIH HHS; N01-HB-07158/HB/NHLBI NIH HHS; N01-HB-07159/HB/NHLBI NIH HHS; N01-HB-07160/HB/NHLBI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antisickling Agents; 0/Hemoglobins; 127-07-1/Hydroxyurea |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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