Mortality and developmental outcome in survivors of two RCTs concerning neonatal allopurinol after birth asphyxia
| Total group of asphyxiated infants | Subgroup of moderately asphyxiated infants* | ||||||
|---|---|---|---|---|---|---|---|
| ALLO (n=28) | CONT (n=26) | p | ALLO (n=16) | CONT (n=17) | p | RR (95% CI) | |
| Mortality, n (%) | |||||||
| Died | 15 (54%) | 16 (62%) | 0.376 | 4 (25%) | 10 (59%) | 0.053 | |
| Survivors | 13 (46%) | 10 (39%) | 12 (75%) | 7 (41%) | |||
| Excluded | 0 | 1† | |||||
| IQ‡ | (n=11) | (n=8) | (n=11) | (n=6) | |||
| Verbal | 92.4 (13.4) | 100.1(21.3) | 0.361 | 92.4 (13.4) | 98.8 (17.1) | 0.414 | |
| Performance | 94.3 (13.6) | 94.0 (16.4) | 0.957 | 94.3 (13.6) | 99.8 (13.9) | 0.470 | |
| Full Scale | 92.8 (13.8) | 96.6 (15.7) | 0.590 | 92.8 (13.8) | 98.7 (14.3) | 0.429 | |
| Long-term neurodevelopmental outcome, n (%) | (n=13) | (n=9) | (n=12) | (n=7) | |||
| Severe disabled§ | 1 (8%) | 1 (11%) | 1.000 | 0 (0%) | 1 (14%) | 0.368 | |
| Mild disabled¶ | 5 (39%) | 4 (44%) | 1.000 | 5 (42%) | 2 (29%) | 0.656 | |
| Normal** | 7 (54%) | 4 (44%) | 0.680 | 7 (58%) | 4 (57%) | 1.000 | |
| Overall long-term outcome, n (%) | |||||||
| Severe adverse outcome†† | 16 (57%) | 17 (68%) | 0.571 | 4 (25%) | 11 (65%) | 0.047 | 0.40 (0.17-0.94)‡‡ |
↵* Subgroup of moderately asphyxiated children; children with a burst suppression pattern or better on the aEEG.
↵† Excluded because of suspected syndrome.
↵‡ Values are reported as mean (SD).
↵§ The two children with a severe disability, both had CP (GMFCS≥3).
↵¶ The group of mild disabled children included children with epilepsy well responding to treatment, hearing impairment or IQ ≥70 to <90.
↵** Normal outcome: IQ≥90, no physical impairment.
↵†† Severe adverse outcome was defined as mortality or severe disability.
↵‡‡ Pooled RR, generated using a Mantel Haenszel approach to stratify by trial.
ALLO, allopurinol; CONT, controls.