Table 4.
Secondary outcomes at 2–5 years corrected gestational age (CA)
| Probiotic group n=337 |
Placebo group n=327 |
Relative risk (95% CI) |
P value | |
| Components of primary outcome: | ||||
| Death before 24 months CA N (%) | 36/548 (6.6) | 35/551 (6.4) | 1.03 (0.66, 1.62) | 0.88 |
| Major neurosensory impairment N (%)* | 56 (16.6) | 56 (17.1) | 0.97 (0.69 to 1.36) | 0.86 |
| Disability, N (%) | 0.72 | |||
| None Mild Moderate Severe |
206 (61.1) 90 (26.7) 27 (8.0) 14 (4.2) |
203 (62.1) 77 (23.5) 30 (9.2) 17 (5.2) |
||
| Cerebral palsy (CP) N (%) | 19 (5.7) | 14 (4.3) | 1.33 (0.68 to 2.61) | 0.41 |
| CP severity | 0.55 | |||
| No CP Mild CP Moderate CP Severe CP |
301 (90.4) 23 (6.9) 3 (0.9) 1 (0.3) |
294 (90.2) 19 (5.8) 3 (0.9) 1 (1.5) |
||
| Motor impairment† N (%) | 31 (9.3) | 24 (7.4) | 1.25 (0.75 to 2.07) | 0.40 |
| Cognitive impairment† N (%) | 39 (11.6) | 40 (12.4) | 0.93 (0.62 to 1.41) | 0.74 |
| Deafness N (%) | 2 (0.6) | 11 (3.4) | 0.18 (0.04 to 0.80) | 0.01 |
| Blindness N (%) | 1 (0.3) | 0 (0.0) | 0.32 | |
| Bayley-III composite scores mean (SD) | ||||
| Mean difference (95% CI) | P value | |||
| Cognitive | 100.4 (17.1) n=299 |
99.2 (15.1) n=298 |
1.2 (−1.4, 3.8) | 0.36 |
| Language | 98.3 (16.8) n=289 |
98.5 (18.1) n=281 |
−0.3 (−3.1, 2.6) | 0.86 |
| Motor | 102.3 (11.6) n=299 |
100.7 (16.8) n=296 |
1.6 (−1.1, 4.3) | 0.24 |
| WPPSI | n=37 | n=25 | Mean difference (95% CI) | |
| FSIQ | 106.0 (21.6) | 1.3 (−8.3, 14.1) | 0.79 | |
| FSIQ<70 | 2 (5.4) | 1 (4.0) | 1.35 (0.1 to 14.1) | 0.80 |
| MABC | n=37 | n=23 | Mean difference (95% CI) | P value |
| <15th centile N (%) | 8 (21.6) | 5 (21.7) | 1.0 (0.4 to 2.7) | 0.99 |
| <5th centile N (%) | 3 (8.1) | 2 (8.7) | 0.9 (0.2 to 5.2) | 0.94 |
| ITSEA | n=165 | n=163 | Mean difference (95% CI) | P value |
| Months corrected age at testing, mean (SD) | 26.7 (3.3) | 27.5 (4.4) | −0.1 (−1.6, 0.1) | 0.09 |
| T scores, mean (SD) | n=165 | n=163 | ||
| Externalising | 48.6 (9.8) | 50.2 (11.4) | −1.7 (−4. 0.6) | 0.16 |
| Internalising | 48.1 (10.6) | 48.6 (11.2) | −0.5 (−2.9, 1.8) | 0.66 |
| Dysregulation | 48.1 (14.1) | 46.5 (12.9) | 1.6 (−1.4, 4.5) | 0.29 |
| Competence | 47.3 (12.0) | 46.4 (12.4) | 1 (−1.7, 3.6) | 0.48 |
| Of concern, n (%) | n=165 | n=163 | Relative risk (95% CI) | |
| Externalising | 15 (9.1) | 16 (9.8) | 0.93 (0.5 to 1.8) | 0.82 |
| Internalising | 16 (9.7) | 15 (9.2) | 1.05 (0.5, 2.1) | 0.88 |
| Dysregulation | 21 (12.7) | 14 (8.5) | 1.49 (0.8 to 2.8) | 0.22 |
| Competence | 21 (12.8) | 27 (16.7) | 0.77 (0.5 to 1.3) | 0.33 |
*Major neurosensory impairment=motor impairment AND/OR cognitive impairment AND/OR blindness AND/OR deafness.
†(Corrected by 0.5SD=7.5 points).
FSIQ, Full Scale Intelligence Quotient; ITSEA, Infant Toddler Social Emotional Assessment; MABC, Movement Assessment Battery for Children; WPPSI, Wechsler Preschool and Primary Scale of Intelligence.
Disability severity: mild disability=GMFCS1and/or Bayley-III cognitive or language composite scores <–1–2SD (77.5–92.5)and/or WPPSI <–1–2SD (70-85); moderate disability=GMFCS2–3and/or Bayley-III cognitive or language composite scores <–2–3SD (62.5–77.5)or WPPSI <–2–3SD (55-70) and/or deafness; severe disability=GMFCS4–5and/or Bayley-III cognitive or language composite scores <–3SD (62.5) or WPPSI <–3SD (55) and/or blindness.
CPseverity: mild CP=GMFCS1; moderate CP=GMFCS2 or 3; severe CP=GMFCS4 or 5.