Table 2.
Outcomes RCT HRC versus conventional monitoring
| Outcome | n/N HRC arm | n/N standard arm | ARR (95% CI) | NNTM (95% CI) | p value |
|---|---|---|---|---|---|
| Mortality at hospital discharge, n/N (%) | 122/1,500 (8.1) | 152/1,489 (10.2) | 2.07 (0.01–4.14) | 49 (24–15,483) | 0.05 |
| Mortality at 18–22 months CA, n/N (%) | 79/327 (24.2) | 99/309 (32.0) | 7.88 (0.91–14.85) | 13 (7–110) | 0.03 |
| Late-onset septicemia, n/N (%) | 358/1,500 (23.9) | 379/1,489 (25.5) | 1.59 (−1.50–4.68) | – | 0.34 |
| Death or NDI, n/N (%) | 127/321 (39.6) | 136/306 (44.4) | 4.88 (−2.84–12.60) | – | 0.22 |
| Death or CP (GMFCS level 2–5), n/N (%) | 102/327 (31.2) | 112/309 (36.2) | 5.05 (−2.29–12.40) | – | 0.18 |
| NDI in survivors, n/N (%) | 53/247 (21.5) | 40/210 (19.1) | −2.41 (−4.97–9.79) | – | 0.56 |
| CP in survivors (GMFCS level 2–5, n/N (%) | 23/246 (9.4) | 13/210 (6.2) | −3.16 (−1.73–8.04) | – | 0.22 |
| Deafness survivors, n/N (%) | 11/248 (4.4) | 1/210 (0.5) | −3.96 (−6.69 to −1.23) | −26 (−15 to −81) | 0.01 |
| Infants with antibiotic treatment, n/N (%) | 1,020/1,500 (68) | 980/1,489 (65) | −2.18 (−5.56–1.19) | – | 0.21 |
| Duration of antibiotic treatment, mean (SD) | 15.7 (19.4) | 15.0 (19.1) | 0.31 | ||
| Days in NICU, mean (SD) | 59.6 (33.7) | 58.7 (34.5) | 0.47 |
NDI, neurodevelopmental impairment, defined as having one of the following cognitive or language composite score on the Bayley Scales of Infant and Toddler Development third edition of <70, GMFCS of >1, hearing impairment, or bilateral visual impairment.
GMFCS, Gross Motor Function Classification System; HRC, heart rate characteristics; ARR, absolute risk reduction; RR, relative risk; NNTM, numbers needed to monitor; CI, confidence interval; SD, standard deviation, NICU, neonatal intensive care unit.