Baseline demographic, clinical, and laboratory characteristics of the NOHARM randomized cohort
| . | Hydroxyurea (N = 104) . | Placebo (N = 103) . | P . |
|---|---|---|---|
| Demographics, N (%) | |||
| Age at enrollment, mean (SD), y | 2.2 (0.9) | 2.3 (0.9) | .3148 |
| Male | 55 (53) | 57 (55) | .8298 |
| Parent completing secondary school | 32 (31) | 35 (34) | .7614 |
| Running water in the home | 14 (13) | 11 (11) | .6885 |
| Growth measures, mean (SD) | |||
| Height, cm | 85.6 (8.8) | 86.3 (8.2) | .5615 |
| Weight, kg | 11.3 (2.1) | 11.5 (2.1) | .4604 |
| Z score (weight for length/height) | −0.40 (1.06) | −0.39 (1.06) | .9316 |
| Past medical history, N (%) | |||
| Dactylitis | 80 (77) | 82 (80) | .7639 |
| Vaso-occlusive crisis | 88/103 (85) | 81/103 (79) | .3421 |
| Stroke | 0 | 0 | — |
| Splenomegaly | 6/93 (6) | 5/99 (5) | .7619* |
| Acute chest syndrome | 21/103 (20) | 13/100 (13) | .2219 |
| Transfusion | 56 (54) | 57 (55) | .9393 |
| Hospitalization within 1 y of enrollment | 65 (63) | 54 (52) | .1851 |
| Laboratory measures, mean (SD) | |||
| Hemoglobin, g/dL | 7.5 (1.1) | 7.6 (1.0) | .5214 |
| MCV, fL | 79 (9) | 80 (9) | .8248 |
| Fetal hemoglobin [HbF/(HbF + HbS)], % | 14.6 (7.1) | 13.3 (6.0) | .1591 |
| ARC (×109/L) | 380 (122) | 381 (112) | .9623 |
| WBC count, ×109/L | 19.0 (7.2) | 18.7 (5.4) | .7148 |
| ANC, ×109/L | 6.5 (3.1) | 6.2 (2.6) | .4023 |
| Platelets, ×109/L | 358 (171) | 416 (138) | .0075 |
| ALT, U/L | 18 (9) | 19 (9) | .5478 |
| Creatinine, mg/dL | 0.28 (0.09) | 0.28 (0.07) | .6068 |
| . | Hydroxyurea (N = 104) . | Placebo (N = 103) . | P . |
|---|---|---|---|
| Demographics, N (%) | |||
| Age at enrollment, mean (SD), y | 2.2 (0.9) | 2.3 (0.9) | .3148 |
| Male | 55 (53) | 57 (55) | .8298 |
| Parent completing secondary school | 32 (31) | 35 (34) | .7614 |
| Running water in the home | 14 (13) | 11 (11) | .6885 |
| Growth measures, mean (SD) | |||
| Height, cm | 85.6 (8.8) | 86.3 (8.2) | .5615 |
| Weight, kg | 11.3 (2.1) | 11.5 (2.1) | .4604 |
| Z score (weight for length/height) | −0.40 (1.06) | −0.39 (1.06) | .9316 |
| Past medical history, N (%) | |||
| Dactylitis | 80 (77) | 82 (80) | .7639 |
| Vaso-occlusive crisis | 88/103 (85) | 81/103 (79) | .3421 |
| Stroke | 0 | 0 | — |
| Splenomegaly | 6/93 (6) | 5/99 (5) | .7619* |
| Acute chest syndrome | 21/103 (20) | 13/100 (13) | .2219 |
| Transfusion | 56 (54) | 57 (55) | .9393 |
| Hospitalization within 1 y of enrollment | 65 (63) | 54 (52) | .1851 |
| Laboratory measures, mean (SD) | |||
| Hemoglobin, g/dL | 7.5 (1.1) | 7.6 (1.0) | .5214 |
| MCV, fL | 79 (9) | 80 (9) | .8248 |
| Fetal hemoglobin [HbF/(HbF + HbS)], % | 14.6 (7.1) | 13.3 (6.0) | .1591 |
| ARC (×109/L) | 380 (122) | 381 (112) | .9623 |
| WBC count, ×109/L | 19.0 (7.2) | 18.7 (5.4) | .7148 |
| ANC, ×109/L | 6.5 (3.1) | 6.2 (2.6) | .4023 |
| Platelets, ×109/L | 358 (171) | 416 (138) | .0075 |
| ALT, U/L | 18 (9) | 19 (9) | .5478 |
| Creatinine, mg/dL | 0.28 (0.09) | 0.28 (0.07) | .6068 |
A total of 208 children were randomized to either hydroxyurea (N = 104) or placebo (N = 104). One participant was later deemed ineligible, and those data were removed from the data set. Values are shown as the mean (SD) or the number of study participants with the measure/total tested for that measure (% affected).
HbS, sickle hemoglobin; MCV, mean corpuscular volume; WBC, white blood cell.
Fisher's exact test because of the low frequency.