Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Brief Summary: The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.


Options:
A: Inclusion Criteria:

* Majority fetal and sickle (FS or SF) hemoglobin pattern confirmed centrally by electrophoresis (screening may begin at 7 months of age)

Exclusion Criteria:

* Chronic transfusion therapy
* Cancer
* Less than 5th percentile (10th percentile for the pilot study) height, weight, or head circumference for age
* Severe developmental delay (e.g., cerebral palsy or other mental retardation, Grade III/IV intraventricular hemorrhage)
* Stroke with neurological deficit
* Surgical splenectomy
* Participating in other clinical intervention trials
* Probable or known diagnosis of Hemoglobin S-Hereditary Persistence of Fetal Hemoglobin
* Known hemoglobin S-beta plus thalassemia (hemoglobin A present)
* Any condition or chronic illness, which in the opinion of the principal investigator, makes participation unadvised or unsafe
* Inability or unwillingness to complete baseline (pre-enrollment) studies, including blood or urine specimen collection, liver-spleen scan, abdominal sonogram, neurological examination, neuropsychological testing, or transcranial Doppler ultrasound (interpretable study not required, but confirmed velocity greater than 200 cm/sec results in ineligibility)
* Previous or current treatment with hydroxyurea (HU) or another anti-sickling drug
* The following exclusion criteria are transient; patients can be re-evaluated for eligibility:

  1. Hemoglobin less than 6.0 gm/dL
  2. Reticulocyte count less than 80,000/cu mm if hemoglobin is less than 9 gm/dL
  3. Neutrophil count less than 2,000/cu mm
  4. Platelet count less than 130,000/cu mm
  5. Blood transfusion in the 2 months prior to study entry unless HbA is less than 10%
  6. ALT greater than twice the upper limit of normal
  7. Ferritin less than 10 ng/ml
  8. Serum creatinine greater than twice the upper limit of normal for age
  9. Bayley standardized mental score below 70
B: Inclusion Criteria:

* Patients from birth up to age 30 years
* Diagnosis of sickle cell disease
* Patients who are receiving hydroxyurea therapy or plan to begin hydroxyurea therapy
C: Inclusion Criteria:

* Homozygous S sickle cell disease
* Diagnosed by newborn screening
* determined to have persistent microalbuminuria
* satisfied criteria for microalbuminuria screening
* parental consent

Exclusion Criteria:

* Asymptomatic bacteriuria on screening urine cultures
* On Hydroxyurea therapy
* Pre-existing complications of SCD which would meet local criteria for HU therapy
D: Inclusion Criteria:

* Sickle cell disease (SS, SC, Sb thalassemia, SD Punjab)
* Affiliation to French Health benefits
* Signed informed consent
* Albuminemia / Creatinemia \>= 3 mg / mmol (on 2 samples)

Exclusion Criteria:

* Albuminemia / Creatinemia \> 100 mg / mmol
* Hypersensibility to enalapril
* Angio-oedemas due to a previous treatment by ACE
* idiopathic or hereditary angio-oedemas
* cerebral echo-doppler
* treatment by lithium digoxine
* treatment by other ACE
* congenital galactosemia
* Pregnancy

Answer: A