Table 3.
Clinical Outcomes and Adverse Events by Treatment group
| Characteristic a | Placebo (N=25) |
Inositol 60 mg/Kg (N=25) |
Inositol 120 mg/Kg (N=24) |
P-value | ||
|---|---|---|---|---|---|---|
| Died prior to discharge | n Yes (%) |
25 3 (12%) |
25 4 (16%) |
24 3 (12%) |
>0.99 | |
| BPD b (On O2 at 36 weeks PMA c) | n Yes (%) |
23 3 (13%) |
21 6 (29%) |
21 9 (43%) |
0.09 | |
| Days on Oxygen | n | 25 | 25 | 24 | 0.22 | |
| Median (range) | 32 (1–108) | 32 (1–120) | 53 (0–120) | |||
| PDA d | n Yes (%) |
25 13 (52%) |
25 7 (28%) |
24 11 (46%) |
0.20 | |
| If PDA d, Indomethacin Rx | n Yes (%) |
13 7 (54%) |
7 4 (57%) |
11 9 (82%) |
0.36 | |
| If PDA d, surgical ligation | n Yes (%) |
13 2 (15%) |
7 3 (43%) |
11 4 (36%) |
0.35 | |
| IVHe grade 3,4 | n Yes (%) |
25 3 (12%) |
24 5 (21%) |
23 1 (4%) |
0.22 | |
| Seizures treated > 72 hours | n Yes (%) |
25 0 |
25 1 (4%) |
24 2 (8%) |
0.31 | |
| Sepsis, late onset | n Yes (%) |
25 7 (28%) |
25 7 (28%) |
24 13 (54%) |
0.09 | |
| NEC f IIA or worse | n Yes (%) |
25 5 (20%) |
25 2 (8%) |
24 2 (8%) |
0.49 | |
| If NEC f, had surgery | n Yes (%) |
5 2 (40%) |
2 1 (50%) |
2 1 (50%) |
>0.99 | |
| Spontaneous GI perforation, no NEC f | n Yes (%) |
25 0 |
25 2 (8%) |
24 0 |
0.32 | |
| Hearing test, failed both ears | n Yes (%) |
21 2 (10%) |
17 0 |
19 1 (5%) |
0.77 | |
| ROP g | Final Status Known Received Surgery for ROP (%) |
8 4 (50%) |
8 2 (25%) |
9 1 (11%) |
0.21 | |
a
number of subjects in the denominator shown because of variation
b
BPD bronchopulmonary dysplasia,
c
PMA postmenstrual age (=gestational age + chronologic age),
d
PDA patent ductus arteriosus,
e
IVH intraventricular hemorrhage,
f
NEC necrotizing enterocolitis,
g
ROP retinopathy of prematurity.