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 severity0.55
 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
Cognitive100.4 (17.1)
n=299
99.2 (15.1)
n=298
1.2 (−1.4, 3.8)0.36
Language98.3 (16.8)
n=289
98.5 (18.1)
n=281
−0.3 (−3.1, 2.6)0.86
Motor102.3 (11.6)
n=299
100.7 (16.8)
n=296
1.6 (−1.1, 4.3)0.24
WPPSIn=37n=25Mean difference (95% CI)
FSIQ106.0 (21.6)1.3 (−8.3, 14.1)0.79
FSIQ<702 (5.4)1 (4.0)1.35 (0.1 to 14.1)0.80
MABCn=37n=23Mean 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
ITSEAn=165n=163Mean 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=165n=163
 Externalising48.6 (9.8)50.2 (11.4)−1.7 (−4. 0.6)0.16
 Internalising48.1 (10.6)48.6 (11.2)−0.5 (−2.9, 1.8)0.66
 Dysregulation48.1 (14.1)46.5 (12.9)1.6 (−1.4, 4.5)0.29
 Competence47.3 (12.0)46.4 (12.4)1 (−1.7, 3.6)0.48
Of concern, n (%)n=165n=163Relative risk (95% CI)
 Externalising15 (9.1)16 (9.8)0.93 (0.5 to 1.8)0.82
 Internalising16 (9.7)15 (9.2)1.05 (0.5, 2.1)0.88
 Dysregulation21 (12.7)14 (8.5)1.49 (0.8 to 2.8)0.22
 Competence21 (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 <12SD (77.5–92.5)and/or WPPSI <12SD (70-85); moderate disability=GMFCS2–3and/or Bayley-III cognitive or language composite scores <23SD (62.5–77.5)or WPPSI <23SD (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.