Table 4.
Health and development outcomes at 2 years in a sample of surviving infants without the primary outcome selected for follow-up
| Decision support (n=3556) | No decision support (n=3510) | Adjusted effect measure (CI) | ||
|---|---|---|---|---|
| PARCA-R composite score | ||||
| Mean (SD) | 98·0 (33·8) | 97·2 (33·4) | Mean difference 0·63 (95% CI −0·98 to 2·25) | |
| Median (IQR) | 98 (73–126) | 97 (72–125) | ·· | |
| Unknown | 175 | 184 | ·· | |
| PARCA-R non-verbal cognition scale | ||||
| Mean (SD) | 27·7 (3·7) | 28·0 (3·6) | Mean difference −0·22 (99% CI −0·44 to 0·01) | |
| Median (IQR) | 28 (26–30) | 28 (26–31) | ·· | |
| PARCA-R vocabulary sub-scale | ||||
| Mean (SD) | 57·4 (27·8) | 56·5 (27·7) | Mean difference 0·82 (99% CI −0·91 to 2·54) | |
| Median (IQR) | 58 (36–81) | 56 (35–80) | ·· | |
| PARCA-R sentence complexity sub-scale | ||||
| Mean (SD) | 12·4 (5·4) | 12·3 (5·3) | Mean difference 0·07 (99% CI −0·26 to 0·41) | |
| Median (IQR) | 12 (9–16) | 12 (9–16) | ·· | |
| Cerebral palsy | ||||
| n (%) | 4 (0·1%) | 4 (0·1%) | RR 0·99 (99% CI 0·16 to 6·10) | |
| Unknown (n) | 111 | 114 | ·· | |
| Non-major or major disability* | ·· | ·· | RR 1·08 (99% CI 0·98 to 1·18) | |
| n (%) | 942 (40·4%) | 840 (37·4%) | ·· | |
| Unknown (n) | 1225 | 1266 | ·· | |
| Major disability* | ||||
| n (%) | 134 (5·7%) | 135 (6·0%) | RR 0·95 (99% CI 0·70 to 1·29) | |
| Unknown (n) | 1225 | 1266 | ·· | |
Missing data are <3% unless otherwise presented; there were no apparent differences in missing data between trial arms. Effect measures were adjusted for stratification factors used in the randomisation (centre and twin birth) and clustering as a result of twins and multiple birth episodes. Stratification factors were not adjusted for in the analysis of infant deaths at 2 years and cerebral palsy because of the small number of events. Crude effect measures were not presented as identical to one decimal place (two decimal places for most outcomes). At 2 years, 29 (0·13%) of 21 508 infants had died in the decision-support group and 35 (0·16%) of 21 597 infants had died in the no-decision-support group (adjusted RR 0·83 [99% CI 0·44–1·59])—all deaths were reported to age 2 years excluding stillbirths (one in the decision-support group and two in the no-decision-support group). Data from Ireland were not included in the numerator (n=1 in the decision-support group) or denominator (n=1754 in decision-support group and n=1752 in the no-decision-support group) because data for deaths after discharge were not available. CI=confidence interval. PARCA-R=Parent Report of Children's Abilities—Revised. RR=risk ratio.
Disability in any of neuromotor function, seizures, auditory function, communication, visual function, cognitive function, or other physical disability.