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Cited by 803Hemoglobinopathies and Related DisordersNeonatal Health and BiochemistryIron Metabolism and Disorders

The DOI matches its Crossref record; 33 of the 35 references it cites were found in a registry or an index.

Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG)

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Wang, Winfred C, Ware, Russell E, Miller, Scott T, Iyer, Rathi V, Casella, James F, Minniti, Caterina P, Rana, Sohail, Thornburg, Courtney D, Rogers, Zora R, Kalpatthi, Ram V, Barredo, Julio C, Brown, R Clark, Sarnaik, Sharada A, Howard, Thomas H, Wynn, Lynn W, Kutlar, Abdullah, Armstrong, F Daniel, Files, Beatrice A, Goldsmith, Jonathan C, Waclawiw, Myron A, Huang, Xiangke, Thompson, Bruce W·2011·The Lancet
DOI 10.1016/s0140-6736(11)60355-3PMC PMC3133619
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Abstract

Background Sickle cell anaemia (SCA) is associated with significant morbidity from acute complications and organ dysfunction beginning in the first year of life. In the first multicenter randomised double-blinded trial in very young children with SCA, the impact of hydroxyurea (hydroxycarbamide) therapy on organ dysfunction, clinical complications, and laboratory findings, and its toxicity, were examined. Methods Eligible subjects had HbSS or Sβ0thalassaemia, were age 9–18 months at randomisation, and were not selected for clinical severity. Subjects received liquid hydroxyurea, 20 mg/kg/day, or placebo for two years. Primary study endpoints were splenic function (qualitative uptake on 99Tc spleen scan) and renal function (glomerular filtration rate by 99mTc-DTPA clearance). Additional evaluations included: blood counts, HbF, chemistry profiles, spleen function biomarkers, urine osmolality, neurodevelopment, transcranial Doppler ultrasonography, growth, and mutagenicity. Study visits occurred every two to four weeks. Findings Ninety-six subjects received hydroxyurea and 97 placebo; 86% completed the study. Significant differences were not seen for the primary endpoints, but suggestive benefit was noted in quantitative measures of spleen function. Hydroxyurea significantly decreased pain and dactylitis with trends for decreased acute chest syndrome, hospitalisation and transfusion. Hydroxyurea increased haemoglobin and HbF and decreased WBC count. Toxicity was limited to mild-moderate neutropaenia. Interpretation Although hydroxyurea treatment did not reduce splenic and renal dysfunction assessed by primary endpoint measures, it resulted in major clinical benefit because of diminished acute complications, favorable haematologic results, and a lack of unexpected toxicities. Based on the safety and efficacy data from this trial, hydroxyurea can now be considered for all very young children with SCA.

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Authors
Wang, W. C., Ware, R. E., Miller, S. T., Iyer, R. V., Casella, J. F., Minniti, C. P., Rana, S., Thornburg, C. D., Rogers, Z. R., Kalpatthi, R. V., Barredo, J. C., Brown, R. C., Sarnaik, S. A., Howard, T. H., Wynn, L. W., Kutlar, A., Armstrong, F. D., Files, B. A., Goldsmith, J. C., Waclawiw, M. A., Huang, X., & Thompson, B. W.
Affiliations
  • St. Jude Children's Research Hospital (US)
  • SUNY Downstate Health Sciences University (US)
  • University of Mississippi Medical Center (US)
  • Johns Hopkins University (US)
  • Children's National (US)
  • Howard University (US)
  • Duke Medical Center (US)
  • The University of Texas Southwestern Medical Center (US)
  • Medical University of South Carolina (US)
  • University of Miami (US)
  • Children's Hospital of Michigan (US)
  • University of Alabama at Birmingham (US)
  • Augusta University (US)
  • Emory University (US)
  • National Heart, Lung, and Blood Institute (US)
  • Clinical Trials and Surveys Corporation (US)
Corresponding author
Wang, Winfred C
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2011-05
Volume
377
Issue
9778
Pages
1663-1672
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(11)60355-3
PMC
PMC3133619
OpenAlex
W2170086069
Semantic Scholar
007f7341f1586c3f34ecd96fa415bd95116f1c85
Cited by
803
References
35
Citations by year
2026: 46 · 2025: 42 · 2024: 57 · 2023: 49 · 2022: 58 · 2021: 54 · 2020: 58 · 2019: 67 · 2018: 50 · 2017: 64 · 2016: 52 · 2015: 61 · 2014: 50 · 2013: 45 · 2012: 25
FWCI
21.72
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (n01hb07156-19-0-1, n01hb07159-25-0-1, n01hb07153-18-0-1, n01hb07155-16-0-0, n01hb07158-17-0-0, n01hb07157-15-0-0, n01hb07152-18-0-0, n01hb07151-17-0-0, n01hb07150-20-0-1, n01hb07160-38-0-1, n01hb07154-21-0-0)
  • National Heart, Lung, and Blood Institute (N01-HB-07154, N01-HB-07157, N01-HB-07160, N01 HB007155, N01-HB07155, N01-HB-07152, N01-HB-07153, N01 HB007150, N01-HB-07151, N01-HB-07158, N01-HB-07150, N01 HB007160, N01-HB-07159, N01-HB-07156)
Topics
  • Health Sciences › Medicine › Genetics (clinical) › Hemoglobinopathies and Related Disorders
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal Health and Biochemistry
  • Health Sciences › Medicine › Hematology › Iron Metabolism and Disorders
Keywords
hydroxyurea, sickle cell disease, infants, spleen function, renal function, acute chest syndrome, pain episodes, fetal hemoglobin, brain development, mutagenicity, drug toxicity, beta-thalassemia, organ dysfunction, growth, transcranial Doppler, glomerular filtration rate, urine osmolality
MeSH terms
Anemia, Sickle Cell, Antisickling Agents, Blood Cell Count, Child Development, Female, Glomerular Filtration Rate, Hemoglobins, Humans, Hydroxyurea, Infant, Male, Osmolar Concentration, Pain, Spleen, United States, Urine, Biomarkers, Technetium Tc 99m Pentetate, Treatment Outcome, Ultrasonography, Doppler, Transcranial, Acute Chest Syndrome

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