Table 1.
Demographics and Clinical Characteristics of Subjects Exposed to Excipients
| Cohort characteristics 106 Subjects n (%) or mean (SD) |
BA 36 Subjects n (%) or mean (SD) |
PG 93 Subjects n (%) or mean (SD) |
ET 91 Subjects n (%) or mean (SD) |
BA, PG, ET 26 Subjects n (%) or mean (SD) |
|
|---|---|---|---|---|---|
| Female | 64 (60.4) | 17 (47.2) | 55 (59.1) | 54 (59.3) | 11 (42) |
| GA, weeks | 27.4 (2.1) | 26.3 (2.2) | 27.4 (2.2) | 27.6 (2.1) | 26.4 (2) |
| BW, grams | 961 (245) | 819 (204) | 958 (242) | 980 (232) | 838 (217) |
| SGA | 10 (9.4) | 6 (16.7) | 8 (8.6) | 7 (7.7) | 4 (15) |
| Antenatal Steroids | 89 (84) | 28 (77.8) | 85 (91.4) | 79 (86.8) | 23 (88) |
| Surfactant | 81 (76.4) | 33 (91.7) | 69 (74.2) | 69 (75.8) | 23 (88) |
| High Frequency Ventilation (^n=102) | 32 (31.4) | 25 (69.4) | 26 (28.9) | 23 (26.1) | 15 (58) |
| PDA | 37 (36.6) | 22 (66.7) | 33 (36.7) | 34 (37.4) | 17 (65) |
| NEC | 15 (14.2) | 12 (33.3) | 11 (11.8) | 13 (14.3) | 9 (34) |
| Surgical NEC | 7 (6.6) | 7 (19.4) | 5 (5.4) | 5 (5.5) | 4 (15) |
| ROP | 51 (48.1) | 26 (81.3) | 46 (52.3) | 50 (54.9) | 22 (84) |
| IVH all stages | 35 (34.7) | 23 (67.7) | 31 (34.4) | 29 (31.9) | 15 (58) |
| IVH (stage 3 or 4) | 13 (12) | 13 (36.1) | 11 (11.8) | 9 (9.9) | 7 (27) |
| Oxygen at 28 days (*n=99) | 74 (74.7) | 30 (83.3) | 65 (73.9) | 70 (76.9) | 24 (92) |
| Oxygen at PMA 36wk (*n=99) | 34 (34.3) | 20 (55.6) | 31 (35.2) | 34 (37.3) | 17 (65) |
| Length of Stay, days | 68.8 (55.3) | 88.6 (59.3) | 68.6 (53.5) | 77.4 (54.8) | 96 (47) |
| SNAPPE II Scores | 32.1 (26.4) | 48.6 (28.9) | 30.3 (25.4) | 27.5 (21.6) | 39 (21) |
| Discharge PMA, weeks | 37.3 (8) | 38.9 (9.1) | 37.3 (7.7) | 38.6 (7.7) | 40.1 (7) |
| Death prior to discharge | 13 (12.2) | 10 (27.8) | 10 (10.8) | 4 (4.4) | 4 (15) |
| Death < 48h of life | 5 (4.7) | 2 (5.6) | 3 (3.2) | 0 (0) | 0 (0) |
GA: gestational age; IVH: Intraventricular Hemorrhage; NEC: Necrotizing Enterocolitis; PDA: Patent Ductus Arteriosus; PMA: Post menstrual age; SGA: small for gestational age; ROP: Retinopathy of Prematurity; SNAPPE II: Score of Neonatal Acute Physiology Perinatal Extension.
^
Denominator reflects 4 neonates who did not receive respiratory support.
*
Denominator based on number alive at that time.