Table 2.
Primary and Neonatal Outcomes By Intention-to-Treat and Sensitivity Analyses (Actual Treatment)
| Intention-to-Treat Analyses | Sensitivity Analyses | |||||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| Outcome | Initial Cohort | 18 Month Cohort | Initial Cohort | 18 Month Cohort | ||||
|
| ||||||||
| DCC (n =100) | ICC (n =99) | DCC (n=82) | ICC (n=79) | DCC (n =97) | ICC (n =111) | DCC (n=74) | ICC (n=87) | |
|
| ||||||||
| IVH – all | 31 (31) | 23 (23) | 26 (32) | 17 (22) | 25 (26) | 27 (24) | 20 (27) | 23 (26) |
|
| ||||||||
| Confirmed LOS | 14 (14) | 13 (13) | 13 (16) | 9 (11) | 14 (14) | 13 (12) | 13 (18) | 9 (10) |
|
| ||||||||
| Deaths | 3 | 6 | 3 | 7 | 3 | 6 | 3 | 7 |
|
| ||||||||
| Motor Scorea | -- | -- | 92.1 ± 15 | 91.2 ± 12 | -- | -- | 93 ± 15 | 90 ± 13 |
| <85 | 14 (19) | 18 (24) | 9 (13)** | 23 (28) | ||||
|
| ||||||||
| <70 | -- | -- | 8 (11) | 4 (5) | -- | -- | 6 (9) | 6 (7) |
|
| ||||||||
| Fine Motor Score | -- | -- | 9.4 ± 2.2 | 9.4 ± 3 | -- | -- | 9.7 ± 2.9 | 9.1 ± 2.4 |
|
| ||||||||
| Gross Motor Score | -- | -- | 8.1 ± 2.6 | 7.7 ± 2.6 | -- | -- | 8.1 ± 2.6 | 7.7 ± 2.6 |
**
p 0.01;
a
Bayley III Composite Motor Score; There were no differences between the groups in ROP, NEC, death or IVH, death or LOS, oxygen use at 36 weeks. Range on Bayleys (46-121) for both groups.