Trial reportBlood2012
Impact of hydroxyurea on clinical events in the BABY HUG trial.
Trial report in Blood, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 122 papers, 10 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia
Who cites it
122 citing papers in PubMed, 10 syntheses or guidelines pooled it, 250 citations in OpenAlex.
- Role of hydroxyurea therapy in the prevention of organ damage in sickle cell disease: a systematic review and meta-analysis.Systematic reviews · 2024Pooled it
- Effects of hydroxyurea on fertility in male and female sickle cell disease patients. A systemic review and meta-analysis.PloS one · 2024Pooled it
- Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2023Pooled it
- Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022Pooled it
- American Society of Hematology 2021 guidelines for sickle cell disease: stem cell transplantation.Blood advances · 2021Guideline
- Interventions for preventing silent cerebral infarcts in people with sickle cell disease.The Cochrane database of systematic reviews · 2020Pooled it
- Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Interventions for preventing silent cerebral infarcts in people with sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Systematic review of interventional sickle cell trials registered in ClinicalTrials.gov.Clinical trials (London, England) · 2015Pooled it
- Hydroxycarbamide exposure and ovarian reserve in women with sickle cell disease in the Multicenter Study of Hydroxycarbamide.British journal of haematology · 2020Trial
- Complications of sickle cell anaemia in children in Northwestern Tanzania.Hematology (Amsterdam, Netherlands) · 2016Trial
- Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: A Phase III international randomized clinical trial.American journal of hematology · 2015Trial
- Immune parameter analysis of children with sickle cell disease on hydroxycarbamide or chronic transfusion therapy.British journal of haematology · 2015Trial
- Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial.Pediatric blood & cancer · 2015Trial
- Immunologic effects of hydroxyurea in sickle cell anemia.Pediatrics · 2014Trial
- Trial
- Hydroxyurea is associated with lower costs of care of young children with sickle cell anemia.Pediatrics · 2013Trial
- Identification of predictive factors for reversal of cerebral vasculopathy in an original longitudinal cohort study in newborns with sickle cell anaemia.British journal of haematology · 2026Article
- Multidimensional Predictors of Disease Severity and Health Outcomes in Patients with Sickle Cell Disease:Saudi medical journal · 2026Observational
62 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
13 authors at 11 institutions in 1 country.
Funding
Abstract
The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups. One hundred and ninety-three subjects were randomized to hydroxyurea (20 mg/kg/d) or placebo; there were 374 patient-years of on-study observation. Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea. Despite expected mild myelosuppression, hydroxyurea was not associated with an increased risk of bacteremia or serious infection. These data provide important safety and efficacy information for clinicians considering hydroxyurea therapy for very young children with sickle cell anemia. This clinical trial is registered with the National Institutes of Health (NCT00006400, www.clinicaltrials.gov).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.