Probiotics, prematurity and neurodevelopment: follow-up of a randomised trial

Susan E Jacobs, Leah Hickey, Susan Donath, Gillian F Opie, Peter J Anderson, Suzanne M Garland, Jeanie L Y Cheong, ProPremsStudy Groups

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Objective To determine the impact of one probiotics combination on the neurodevelopment of very preterm children at 2–5 years corrected gestational age (CA). Design Follow-up study of survivors of a double-blinded, placebo-controlled, randomised trial of probiotic effects on late-onset sepsis in very preterm infants that found reduced necrotising enterocolitis. Setting 10 tertiary perinatal centres in Australia and New Zealand. Patients 1099 very preterm infants born <32 weeks’ gestation and weighing <1500 g. Intervention Probiotics (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis) or placebo administered from birth until discharge home or term CA, whichever came sooner. Main outcome measures Major neurodevelopmental impairment comprised any of moderate/severe cerebral palsy (Gross Motor Function Classification System score 2–5), motor impairment (Bayley-III Motor Composite Scale <–2SD or Movement Assessment Battery for Children <15th centile if >42 months’ CA), cognitive impairment (Bayley-III Composite Cognitive or Language Scales <–2SD or Wechsler Preschool and Primary Scale of Intelligence Full Scale Intelligence Quotient <–2SD if >42 months’ CA), blindness or deafness. Results Outcome data were available for 735 (67%) participants, with 71 deaths and 664/1028 survivors assessed at a mean age of 30 months. Survival free of major neurodevelopmental impairment was comparable between groups (probiotics 281 (75.3%) vs placebo 271 (74.9%); relative risk 1.01 (95% CI 0.93 to 1.09)). Rates of deafness were lower in probiotic-treated children (0.6% vs 3.4%). Conclusion Administration of the probiotics combination Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis to very preterm babies from soon after birth until discharge home or term CA did not adversely affect neurodevelopment or behaviour in early childhood.
Original languageEnglish
Article numbere000176
Number of pages9
JournalBMJ Paediatrics Open
Volume1
Issue number1
DOIs
Publication statusPublished - 25 Nov 2017
Externally publishedYes

Cite this

Jacobs, S. E., Hickey, L., Donath, S., Opie, G. F., Anderson, P. J., Garland, S. M., ... ProPremsStudy Groups (2017). Probiotics, prematurity and neurodevelopment: follow-up of a randomised trial. BMJ Paediatrics Open, 1(1), [e000176]. https://doi.org/10.1136/bmjpo-2017-000176
Jacobs, Susan E ; Hickey, Leah ; Donath, Susan ; Opie, Gillian F ; Anderson, Peter J ; Garland, Suzanne M ; Cheong, Jeanie L Y ; ProPremsStudy Groups. / Probiotics, prematurity and neurodevelopment : follow-up of a randomised trial. In: BMJ Paediatrics Open. 2017 ; Vol. 1, No. 1.
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title = "Probiotics, prematurity and neurodevelopment: follow-up of a randomised trial",
abstract = "Objective To determine the impact of one probiotics combination on the neurodevelopment of very preterm children at 2–5 years corrected gestational age (CA). Design Follow-up study of survivors of a double-blinded, placebo-controlled, randomised trial of probiotic effects on late-onset sepsis in very preterm infants that found reduced necrotising enterocolitis. Setting 10 tertiary perinatal centres in Australia and New Zealand. Patients 1099 very preterm infants born <32 weeks’ gestation and weighing <1500 g. Intervention Probiotics (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis) or placebo administered from birth until discharge home or term CA, whichever came sooner. Main outcome measures Major neurodevelopmental impairment comprised any of moderate/severe cerebral palsy (Gross Motor Function Classification System score 2–5), motor impairment (Bayley-III Motor Composite Scale <–2SD or Movement Assessment Battery for Children <15th centile if >42 months’ CA), cognitive impairment (Bayley-III Composite Cognitive or Language Scales <–2SD or Wechsler Preschool and Primary Scale of Intelligence Full Scale Intelligence Quotient <–2SD if >42 months’ CA), blindness or deafness. Results Outcome data were available for 735 (67{\%}) participants, with 71 deaths and 664/1028 survivors assessed at a mean age of 30 months. Survival free of major neurodevelopmental impairment was comparable between groups (probiotics 281 (75.3{\%}) vs placebo 271 (74.9{\%}); relative risk 1.01 (95{\%} CI 0.93 to 1.09)). Rates of deafness were lower in probiotic-treated children (0.6{\%} vs 3.4{\%}). Conclusion Administration of the probiotics combination Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis to very preterm babies from soon after birth until discharge home or term CA did not adversely affect neurodevelopment or behaviour in early childhood.",
author = "Jacobs, {Susan E} and Leah Hickey and Susan Donath and Opie, {Gillian F} and Anderson, {Peter J} and Garland, {Suzanne M} and Cheong, {Jeanie L Y} and {ProPremsStudy Groups}",
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Jacobs, SE, Hickey, L, Donath, S, Opie, GF, Anderson, PJ, Garland, SM, Cheong, JLY & ProPremsStudy Groups 2017, 'Probiotics, prematurity and neurodevelopment: follow-up of a randomised trial' BMJ Paediatrics Open, vol. 1, no. 1, e000176. https://doi.org/10.1136/bmjpo-2017-000176

Probiotics, prematurity and neurodevelopment : follow-up of a randomised trial. / Jacobs, Susan E; Hickey, Leah ; Donath, Susan; Opie, Gillian F; Anderson, Peter J; Garland, Suzanne M; Cheong, Jeanie L Y; ProPremsStudy Groups.

In: BMJ Paediatrics Open, Vol. 1, No. 1, e000176, 25.11.2017.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Probiotics, prematurity and neurodevelopment

T2 - follow-up of a randomised trial

AU - Jacobs, Susan E

AU - Hickey, Leah

AU - Donath, Susan

AU - Opie, Gillian F

AU - Anderson, Peter J

AU - Garland, Suzanne M

AU - Cheong, Jeanie L Y

AU - ProPremsStudy Groups

PY - 2017/11/25

Y1 - 2017/11/25

N2 - Objective To determine the impact of one probiotics combination on the neurodevelopment of very preterm children at 2–5 years corrected gestational age (CA). Design Follow-up study of survivors of a double-blinded, placebo-controlled, randomised trial of probiotic effects on late-onset sepsis in very preterm infants that found reduced necrotising enterocolitis. Setting 10 tertiary perinatal centres in Australia and New Zealand. Patients 1099 very preterm infants born <32 weeks’ gestation and weighing <1500 g. Intervention Probiotics (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis) or placebo administered from birth until discharge home or term CA, whichever came sooner. Main outcome measures Major neurodevelopmental impairment comprised any of moderate/severe cerebral palsy (Gross Motor Function Classification System score 2–5), motor impairment (Bayley-III Motor Composite Scale <–2SD or Movement Assessment Battery for Children <15th centile if >42 months’ CA), cognitive impairment (Bayley-III Composite Cognitive or Language Scales <–2SD or Wechsler Preschool and Primary Scale of Intelligence Full Scale Intelligence Quotient <–2SD if >42 months’ CA), blindness or deafness. Results Outcome data were available for 735 (67%) participants, with 71 deaths and 664/1028 survivors assessed at a mean age of 30 months. Survival free of major neurodevelopmental impairment was comparable between groups (probiotics 281 (75.3%) vs placebo 271 (74.9%); relative risk 1.01 (95% CI 0.93 to 1.09)). Rates of deafness were lower in probiotic-treated children (0.6% vs 3.4%). Conclusion Administration of the probiotics combination Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis to very preterm babies from soon after birth until discharge home or term CA did not adversely affect neurodevelopment or behaviour in early childhood.

AB - Objective To determine the impact of one probiotics combination on the neurodevelopment of very preterm children at 2–5 years corrected gestational age (CA). Design Follow-up study of survivors of a double-blinded, placebo-controlled, randomised trial of probiotic effects on late-onset sepsis in very preterm infants that found reduced necrotising enterocolitis. Setting 10 tertiary perinatal centres in Australia and New Zealand. Patients 1099 very preterm infants born <32 weeks’ gestation and weighing <1500 g. Intervention Probiotics (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis) or placebo administered from birth until discharge home or term CA, whichever came sooner. Main outcome measures Major neurodevelopmental impairment comprised any of moderate/severe cerebral palsy (Gross Motor Function Classification System score 2–5), motor impairment (Bayley-III Motor Composite Scale <–2SD or Movement Assessment Battery for Children <15th centile if >42 months’ CA), cognitive impairment (Bayley-III Composite Cognitive or Language Scales <–2SD or Wechsler Preschool and Primary Scale of Intelligence Full Scale Intelligence Quotient <–2SD if >42 months’ CA), blindness or deafness. Results Outcome data were available for 735 (67%) participants, with 71 deaths and 664/1028 survivors assessed at a mean age of 30 months. Survival free of major neurodevelopmental impairment was comparable between groups (probiotics 281 (75.3%) vs placebo 271 (74.9%); relative risk 1.01 (95% CI 0.93 to 1.09)). Rates of deafness were lower in probiotic-treated children (0.6% vs 3.4%). Conclusion Administration of the probiotics combination Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis to very preterm babies from soon after birth until discharge home or term CA did not adversely affect neurodevelopment or behaviour in early childhood.

U2 - 10.1136/bmjpo-2017-000176

DO - 10.1136/bmjpo-2017-000176

M3 - Article

VL - 1

JO - BMJ Paediatrics Open

JF - BMJ Paediatrics Open

SN - 2399-9772

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ER -