Table 1.
Neonatal characteristics and neurologic outcome in Boston Bumetanide Trial subjects.
| Randomized | Non-randomized | ||
|---|---|---|---|
|
|
|
||
| Neonatal characteristics | Bumetanide (n=27) | Control (n=16) | (n=58) |
| Male, n (%) | 14 (52) | 7 (44) | 32 (55) |
| Gestational age, w, median (IQR) | 39 (39, 40) | 40 (39, 41) | 39 (38, 40) |
| Birth weight, kg, median (IQR) | 3.4 (3.0, 3.7) | 3.3 (3.0, 3.5) | 3.2 (3.0, 3.6) |
| Race, n (%) | |||
| White | 23 (96) | 12 (92) | 33 (77) |
| Black/African American | 0 | 0 | 8 (19) |
| Other | 1 (4) | 1 (8) | 2 (5) |
| Unreported | 3 | 3 | 15 |
| Ethnicity, Hispanic or Latino, n (%) | 2 (7) | 4 (25) | 11 (19) |
| Neurologic diagnosis, n (%) | |||
| HIE | 14 (52) | 8 (50) | 45 (78) |
| Stroke | 7 (26) | 0 | 11 (19) |
| ICH | 3 (11) | 4 (25) | 2 (3) |
| Othera | 3 (11) | 4 (25) | 0 |
| Received therapeutic hypothermia, n (%) | 10 (37) | 5 (31) | 42 (72) |
| Clinical or EEG-confirmed neonatal seizures, n (%) | 27 (100) | 16 (100) | 29 (50) |
| Neonatal seizure burden, min/hr, median (IQR) | 3.1 (1.3, 4.9) | 1.2 (0.3, 2.7) | 0.0 (0.0, 0.9) |
| Neonatal status epilepticus, n (%) | 11 (41) | 1 (6) | 5 (9) |
| EEG duration, hr, median (IQR) | 88.4 (71.2, 99.9) | 81.9 (69.6, 95.6) | 64.5 (47.9, 83.0) |
| Neurodevelopmental testing | (n=21) | (n=12) | (n=39) |
| Age at testing, m, median (IQR) | 19 (18, 20) | 19 (18, 22) | 19 (18, 22) |
| Bayley-III Composite Scores, mean ± SD | |||
| Cognitive | 88.2 ± 16.9 | 90.6 ± 16.7 | 95.0 ± 17.3 |
| Language | 86.5 ± 17.6 | 87.9 ± 20.0 | 90.0 ± 17.6 |
| Motor | 84.4 ± 20.3 | 92.3 ± 21.1 | 93.5 ± 16.6 |
| Vineland-II Composite Scores, mean ± SD | |||
| Adaptive Behavior | 89.7 ± 12.0 | 78.8 ± 23.5 | 92.3 ± 16.0 |
| Communication | 88.4 ± 12.2 | 81.2 ± 22.9 | 90.2 ± 17.5 |
| Motor Skills | 88.8 ± 19.0 | 77.6 ± 31.3 | 96.4 ± 20.1 |
| Post-neonatal outcome, n/total (%) | |||
| Post-neonatal seizure(s) | 9/26 (35) | 4/13 (31) | 4/51 (8) |
| Confirmed SNHL | 2/26 (8) | 0/13 (0) | 1/54 (2) |
| Suspected or confirmed CVI | 0/24 (0) | 3/13 (23) | 1/46 (2) |
Abbreviations: IQR, interquartile range; HIE, hypoxic-ischemic encephalopathy; ICH, intracranial hemorrhage; SD, standard deviation; SNHL, sensorineural hearing loss; CVI, cerebral visual impairment
a
Other neurologic diagnoses included brain malformation, confirmed genetic disorder, acute meningoencephalitis.