Table 3.
Clinical Diagnoses Through Hospital discharge
| Dose group (mg/kg/day) | |||||
|---|---|---|---|---|---|
|
| |||||
| Co-morbidities | 0 (N=35) | 10 (N=29) | 40 (N=30) | 80 (N=28) | P-valueb |
| Death (through NRN statusa) | 6 (17%) | 2 (7%) | 6 (20%) | 1 (4%) | 0.16 |
| BPD (O2 at 36 weeks PMA or prior death from BPD) | 11 (38%) | 7 (26%) | 7 (30%) | 8 (30%) | 0.81 |
| Respiratory Distress Syndrome | 34 (97%) | 29 (100%) | 30 (100%) | 27 (96%) | 0.72 |
| PDA | 13 (37%) | 14 (48%) | 14 (47%) | 10 (36%) | 0.68 |
| PDA (received surgery) | 3 (9%) | 3 (10%) | 1 (3%) | 3 (11%) | 0.75 |
| c IVH (any) | 13 (38%) | 4 (14%) | 10 (34%) | 5 (18%) | 0.08 |
| IVH (grade III/IV) | 10 (29%) | 2 (7%) | 6 (21%) | 2 (7%) | 0.05 |
| Seizures (Rx for >72 hrs) | 2 (6%) | 0 | 1 (3%) | 0 | 0.62 |
| Cystic areas in parenchyma (within 28 days of birth) | 2 (15%) | 0 | 1 (10%) | 1 (14%) | 1.00 |
| Sepsis (early onset) | 0 | 0 | 1 (3%) | 0 | 0.71 |
| Sepsis (late onset) | 4 (11%) | 6 (21%) | 7 (23%) | 5 (18%) | 0.63 |
| d NEC (suspected or proven) | 5 (14%) | 1 (3%) | 4 (13%) | 1 (4%) | 0.28 |
| NEC (requiring surgery) | 3 (9%) | 0 | 2 (7%) | 0 | 0.17 |
| Spontaneous e GI perforation | 2 (6%) | 0 | 2 (7%) | 1 (4%) | 0.72 |
| Severe ROPf | 5/27(9%) | 3/26(12%) | 2/24 (8%) | 2/23(9%) | 0.72 |
| Hearing screen failed (either ear) | 1 (4%) | 1 (4%) | 4 (20%) | 3 (14%) | 0.25 |
a
NRN status = Neonatal Research Network definition: age of earliest of death, discharge, transfer, or 120 days after birth.
b
P-values calculated by testing the null hypothesis of equality across all 4 treatment groups using Fisher’s exact tests.
c
IVH intraventricular hemorrhage,
d
NEC necrotizing enterocolitis,
e
GI gastrointestinal,
f
Retinopathy of Prematurity meeting criteria for treatment or treated with laser, cryotherapy or anti-VEGF injection among those who survived for evaluation. With the 6 adjudicated ROP outcomes included, rates were similar (17%, 11%, 8% and 8% respectively). The denominators for BPD are all enrolled.