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Study Detail

Study ID	1018
Name	Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia
Contact Email	biolincc@imsweb.com
Acronym	Baby HUG
Period	2000 - 2009
Design	Clinical Trial
Study PI	Multiple PI's
Institution	Multiple institutes
URL	https://biolincc.nhlbi.nih.gov/studies/baby_hug/
CTGovID	https://clinicaltrials.gov/ct2/show/NCT00006400
Funding Agency	NHLBI, NICHD
Grant Number	N01-HB-07150 to N01-HB-07160

Overview	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.
Focus Areas	Hydroxyurea Therapy
Outcomes	1. Treatment Differences of the Change in Qualitative Splenic Function From Baseline [ Time Frame: Before initiation of treatment and at 2 years ] 2. Change From Baseline in the Renal Function That Was Measured by Diethylenetriaminepentaacetic Acid (DTPA) Glomerular Filtration Rate (GFR) [ Time Frame: Before initiation of treatment and at 2 years ] 3. Change From Baseline in the Renal Function That Was Measured by Glomerular Filtration Rate (GFR) (Calculated Using Schwartz Formula) [ Time Frame: Before initiation of treatment and at 2 years ] 4. Change From Baseline in the Renal Function That Was Measured by GFR (Calculated Using New Schwartz Formula) [ Time Frame: Before initiation of treatment and at 2 years ]

Data Location	BioLINCC, BioData Catalyst
Biospecimen Available	N/A
Data Consent	Data sharing via BioLINCC; use of data is limited to research on sickle cell anemia and related disorders.
Biospecimen Consent	Consent for use of cells, blood, or other samples for future research.
Contact Consent	Yes, with permission on consent
Genomic Data	No

Age Range	9–18 months
No. Participants	193
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	1. Chronic transfusion therapy 2. Cancer 3. Less than 5th percentile (10th percentile for the pilot study) height, weight, or head circumference for age 4. Severe developmental delay (e.g., cerebral palsy or other mental retardation, Grade III/IV intraventricular hemorrhage) 5. Stroke with neurological deficit 6. Surgical splenectomy 7. Participating in other clinical intervention trials 8. Probable or known diagnosis of Hemoglobin S-Hereditary Persistence of Fetal Hemoglobin 9. Known hemoglobin S-beta plus thalassemia (hemoglobin A present) 10. Any condition or chronic illness, which in the opinion of the principal investigator, makes participation unadvised or unsafe 11. 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) 12. Previous or current treatment with hydroxyurea (HU) or another anti-sickling drug 13. The following exclusion criteria are transient; patients can be re-evaluated for eligibility:1. Hemoglobin less than 6.0 gm/dL2. Reticulocyte count less than 80,000/cu mm if hemoglobin is less than 9 gm/dL3. Neutrophil count less than 2,000/cu mm4. Platelet count less than 130,000/cu mm5. 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 normal7. Ferritin less than 10 ng/ml8. Serum creatinine greater than twice the upper limit of normal for age9. Bayley standardized mental score below 70

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Study Publications

Adherence to study medication and visits: data from the BABY HUG trial.
Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG).

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Mental Health (0)

Mental Health (0)

Neurodevelopment (73)

Neurodevelopment (73)

Data Element	Variables
Achenbach Child Behavior Checklist (CBCL)
Bayley Scale of Infant and Toddler Development	ADJ_DAYS ADJ_MO BEHPCTL BEHRAW BRCHAGMN BRCHAGYR BRPMAGMN BRPMAGYR CARE40G MEN95CIH MEN95CIL MENMDI MENRAW MLCHAGMN MLCHAGYR MLPMAGMN MLPMAGYR MOT95CIH MOT95CIL MOTPDI MOTRAW MRCHAGMN MRCHAGYR MRPMAGMN MRPMAGYR
Behavior Rating Inventory of Executive Function (BRIEF)
California Verbal Learning Test
Children's Memory Scale
Connor's Continuous Performance Test II	COMMI_G COMMI_P COMMI_T COMMI_V DETECT_G DETECT_P DETECT_T DETECT_V OMI_G OMI_P OMI_T OMI_V PERS_G PERS_P PERS_T PERS_V RESP_G RESP_P RESP_T RESP_V RT_G RT_P RT_T RT_V RTBCHG_G RTBCHG_P RTBCHG_T RTBCHG_V RTICHG_G RTICHG_P RTICHG_T RTICHG_V RTSE_G RTSE_P RTSE_T RTSE_V SEBCHG_G SEBCHG_P SEBCHG_T SEBCHG_V SEICHG_G SEICHG_P SEICHG_T SEICHG_V VARI_G VARI_P VARI_T VARI_V
Delis-Kaplan Executive Function System (D-KEFS)
NeuroQOL Cognitive Function
Peabody Picture Vocabulary Test (PPVT)

Neuropsychological (406)

Neuropsychological (406)

Data Element	Variables
Adaptive Behavior Assessment System-II
Adverse Childhood Experience Questionnaire (ACE-Q)
Beery Developmental Test of Visual-Motor Integration
Benton Tactile Form Perception Test
Mini Mental Status Examination (MMSE)
Oral Verbal Fluency Test
PROMIS Cognitive Function
Purdue Pegboard (SPA version)
Test of Everyday Attention (TEA)
Vineland Adaptive Behavior Summary	CARE_OTHER CARE41G CDENDROW CDSTROW CHRAGEMN CHRAGEYR COM95CL COMPCTL COMRAW COMSTRD DDENDROW DDSTROW DLS95CL DLSPCTL DLSRAW DLSSTRD MSENDROW MSSTROW MTSK95CL MTSKPCTL MTSKRAW MTSKSTRD SDENDROW SDSTROW SOC95CL SOCPCTL SOCRAW SOCSTRD
Wechsler Intelligence Scales	AGE_MONTHS AGE_YEARS BD BD_1 BD_10 BD_11 BD_12 BD_13 BD_14 BD_15 BD_16 BD_17 BD_18 BD_19 BD_2 BD_20 BD_3 BD_4 BD_5 BD_6 BD_7 BD_8 BD_9 BD_SCORE CD CMPHN_1 CMPHN_10 CMPHN_11 CMPHN_12 CMPHN_13 CMPHN_14 CMPHN_15 CMPHN_16 CMPHN_17 CMPHN_18 CMPHN_19 CMPHN_2 CMPHN_20 CMPHN_3 CMPHN_4 CMPHN_5 CMPHN_6 CMPHN_7 CMPHN_8 CMPHN_9 CMPHN_SCORE CO COD_SCORE DS FAIQ FSIQ_COMP FSIQ_CONFINT FSIQ_CONFINT_HIGH FSIQ_PERCENT FSIQ_SCALED GL_COMP GL_CONFINT GL_CONFINT_HIGH GL_PERCENT GL_SCALED INFO_1 INFO_10 INFO_11 INFO_12 INFO_13 INFO_14 INFO_15 INFO_16 INFO_17 INFO_18 INFO_19 INFO_2 INFO_20 INFO_21 INFO_22 INFO_23 INFO_24 INFO_25 INFO_26 INFO_27 INFO_28 INFO_29 INFO_3 INFO_30 INFO_31 INFO_32 INFO_33 INFO_34 INFO_4 INFO_5 INFO_6 INFO_7 INFO_8 INFO_9 INFO_SCORE LN MR MR_1 MR_10 MR_11 MR_12 MR_13 MR_14 MR_15 MR_16 MR_17 MR_18 MR_19 MR_2 MR_20 MR_21 MR_22 MR_23 MR_24 MR_25 MR_26 MR_27 MR_28 MR_29 MR_3 MR_4 MR_5 MR_6 MR_7 MR_8 MR_9 MR_SCORE OA_1 OA_10 OA_11 OA_12 OA_13 OA_14 OA_2 OA_3 OA_4 OA_5 OA_6 OA_7 OA_8 OA_9 OA_SCORE PC PCOMP_1 PCOMP_10 PCOMP_11 PCOMP_12 PCOMP_13 PCOMP_14 PCOMP_15 PCOMP_16 PCOMP_17 PCOMP_18 PCOMP_19 PCOMP_2 PCOMP_20 PCOMP_21 PCOMP_22 PCOMP_23 PCOMP_24 PCOMP_25 PCOMP_26 PCOMP_27 PCOMP_28 PCOMP_29 PCOMP_3 PCOMP_30 PCOMP_31 PCOMP_32 PCOMP_4 PCOMP_5 PCOMP_6 PCOMP_7 PCOMP_8 PCOMP_9 PCOMP_SCORE PCON_1 PCON_10 PCON_11 PCON_12 PCON_13 PCON_14 PCON_15 PCON_16 PCON_17 PCON_18 PCON_19 PCON_2 PCON_20 PCON_21 PCON_22 PCON_23 PCON_24 PCON_25 PCON_26 PCON_27 PCON_28 PCON_3 PCON_4 PCON_5 PCON_6 PCON_7 PCON_8 PCON_9 PCON_SCORE PIQ_COMP PIQ_CONFINT PIQ_CONFINT_HIGH PIQ_PERCENT PIQ_SCALED PN_1 PN_10 PN_11 PN_12 PN_13 PN_14 PN_15 PN_16 PN_17 PN_18 PN_19 PN_2 PN_20 PN_21 PN_22 PN_23 PN_24 PN_25 PN_26 PN_27 PN_28 PN_29 PN_3 PN_30 PN_4 PN_5 PN_6 PN_7 PN_8 PN_9 PN_SCORE PRI PS_COMP PS_CONFINT PS_CONFINT_HIGH PS_PERCENT PS_SCALED PSI RV_1 RV_10 RV_11 RV_12 RV_13 RV_14 RV_15 RV_16 RV_17 RV_18 RV_19 RV_2 RV_20 RV_21 RV_22 RV_23 RV_24 RV_25 RV_26 RV_27 RV_28 RV_29 RV_3 RV_30 RV_31 RV_32 RV_33 RV_34 RV_35 RV_36 RV_37 RV_38 RV_4 RV_5 RV_6 RV_7 RV_8 RV_9 RV_SCORE SI SIM_1 SIM_10 SIM_11 SIM_12 SIM_13 SIM_14 SIM_15 SIM_16 SIM_17 SIM_18 SIM_19 SIM_2 SIM_20 SIM_21 SIM_22 SIM_23 SIM_24 SIM_3 SIM_4 SIM_5 SIM_6 SIM_7 SIM_8 SIM_9 SIM_SCORE SS SS_SCORE VC VCI VIQ_COMP VIQ_CONFINT VIQ_CONFINT_HIGH VIQ_PERCENT VIQ_SCALED VOC_1 VOC_10 VOC_11 VOC_12 VOC_13 VOC_14 VOC_15 VOC_16 VOC_17 VOC_18 VOC_19 VOC_2 VOC_20 VOC_21 VOC_22 VOC_23 VOC_24 VOC_25 VOC_3 VOC_4 VOC_5 VOC_6 VOC_7 VOC_8 VOC_9 VOC_SCORE WMI WR_1 WR_10 WR_11 WR_12 WR_13 WR_14 WR_15 WR_16 WR_17 WR_18 WR_19 WR_2 WR_20 WR_21 WR_22 WR_23 WR_24 WR_25 WR_26 WR_27 WR_28 WR_3 WR_4 WR_5 WR_6 WR_7 WR_8 WR_9 WR_SCORE
Wechsler Memory Scale
Wisconsin Card Sorting Test
Woodcock-Johnson Revised, Tests of Achievement
Woodcock-Johnson, Revised, Tests of Cognitive Ability

Pain (0)

Pain (0)

Physical Function (4)

Physical Function (4)

Data Element	Variables
6-Minute Walk Test
PROMIS Physical Functioning
Tanner Stage	F_BRSTS F_P_HAIR M_GNTLS M_P_HAIR

Psychosocial (0)

Psychosocial (0)

Quality of Care (0)

Quality of Care (0)

Quality of Life (169)

Quality of Life (169)

Data Element	Variables
ASCQ-Me SCD Medical History Checklist
ASCQ-Me Sexual Health
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)	FCRPT_A1 FCRPT_A2 FCRPT_A3 FCRPT_A4 FCRPT_A5 FCRPT_A6 FCRPT_B1 FCRPT_B2 FCRPT_B3 FCRPT_B4 FCRPT_B5 FCRPT_B6 FCRPT_C1 FCRPT_C2 FCRPT_C3 FCRPT_C4 FCRPT_C5 FCRPT_C6 GCRPT_A1 GCRPT_A2 GCRPT_A3 GCRPT_A4 GCRPT_A5 GCRPT_A6 GCRPT_A7 GCRPT_A8 GCRPT_B1 GCRPT_B2 GCRPT_B3 GCRPT_B4 GCRPT_B5 GCRPT_C1 GCRPT_C2 GCRPT_C3 GCRPT_C4 GCRPT_C5 GCRPT_D1 GCRPT_D2 GCRPT_D3 GCRPT_D4 GCRPT_D5 SCRPT_A1 SCRPT_A2 SCRPT_A3 SCRPT_A4 SCRPT_A5 SCRPT_A6 SCRPT_A7 SCRPT_A8 SCRPT_A9 SCRPT_B1 SCRPT_B10 SCRPT_B2 SCRPT_B3 SCRPT_B4 SCRPT_B5 SCRPT_B6 SCRPT_B7 SCRPT_B8 SCRPT_B9 SCRPT_C1 SCRPT_C2 SCRPT_D1 SCRPT_D2 SCRPT_D3 SCRPT_D4 SCRPT_D5 SCRPT_E1 SCRPT_E2 SCRPT_F1 SCRPT_F2 SCRPT_G1 SCRPT_G2 SCRPT_G3 SCRPT_G4 SCRPT_G5 SCRPT_G6 SCRPT_G7 SCRPT_H1 SCRPT_H2 SCRPT_H3 SCRPT_I1 SCRPT_I2 SCRPT_I3
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)	CHC_6M FPRPT_A1 FPRPT_A2 FPRPT_A3 FPRPT_A4 FPRPT_A5 FPRPT_A6 FPRPT_B1 FPRPT_B2 FPRPT_B3 FPRPT_B4 FPRPT_B5 FPRPT_B6 FPRPT_C1 FPRPT_C2 FPRPT_C3 FPRPT_C4 FPRPT_C5 FPRPT_C6 GPRPT_A1 GPRPT_A2 GPRPT_A3 GPRPT_A4 GPRPT_A5 GPRPT_A6 GPRPT_A7 GPRPT_A8 GPRPT_B1 GPRPT_B2 GPRPT_B3 GPRPT_B4 GPRPT_B5 GPRPT_C1 GPRPT_C2 GPRPT_C3 GPRPT_C4 GPRPT_C5 GPRPT_D1 GPRPT_D2 GPRPT_D3 GPRPT_D4 GPRPT_D5 SPRPT_A1 SPRPT_A2 SPRPT_A3 SPRPT_A4 SPRPT_A5 SPRPT_A6 SPRPT_A7 SPRPT_A8 SPRPT_A9 SPRPT_B1 SPRPT_B10 SPRPT_B2 SPRPT_B3 SPRPT_B4 SPRPT_B5 SPRPT_B6 SPRPT_B7 SPRPT_B8 SPRPT_B9 SPRPT_C1 SPRPT_C2 SPRPT_D1 SPRPT_D2 SPRPT_D3 SPRPT_D4 SPRPT_D5 SPRPT_E1 SPRPT_E2 SPRPT_F1 SPRPT_F2 SPRPT_G1 SPRPT_G2 SPRPT_G3 SPRPT_G4 SPRPT_G5 SPRPT_G6 SPRPT_G7 SPRPT_H1 SPRPT_H2 SPRPT_H3 SPRPT_I1 SPRPT_I2 SPRPT_I3
PROMIS Global Health
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey

Sleep (0)

Sleep (0)

Technology Support (0)

Technology Support (0)

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