Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.

S Agrawal, C F Pestell, J Granich, S Rao, E Nathan, J A Wray, A J O Whitehouse, S Patole

Journal: Early human development 2021;151():105165

PMID: 32871454

Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND

Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.

AIM

To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.

STUDY DESIGN

Follow up study.

SUBJECTS

Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.

OUTCOMES

Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.

MEASURES

Continuous scores derived from all the measures.

RESULTS

67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).

CONCLUSION

There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.

Address: Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: [email protected].; School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia.; Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.

DOI: 10.1016/j.earlhumdev.2020.105165

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MeSH Terms: Academic Performance, Bifidobacterium breve, Child, Child Development, Child, Preschool, Data Accuracy, Developmental Disabilities, Female, Humans, Infant, Newborn, Infant, Premature, Lost to Follow-Up, Male, Probiotics, Western Australia