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Randomized Controlled Trial
. 2025 Aug;114(8):1817-1824.
doi: 10.1111/apa.70030. Epub 2025 Feb 13.

Neurodevelopment and Growth 2 Years After Probiotic Supplementation in Extremely Preterm Infants: A Randomised Trial

Erik Wejryd  1   2 , Giovanna Marchini  3 , Peter Bang  1   4 , Baldvin Jonsson  3   5 , Ulrika Ådén  1   3   5 , Thomas Abrahamsson  1   4
Affiliations
Randomized Controlled Trial

Neurodevelopment and Growth 2 Years After Probiotic Supplementation in Extremely Preterm Infants: A Randomised Trial

Erik Wejryd et al. Acta Paediatr. 2025 Aug.

Abstract

Aim: To assess neurodevelopment and growth at 2 years corrected age in children born extremely preterm, supplemented with Limosilactobacillus reuteri or placebo.

Methods: Design: Secondary analysis of register data after randomised double-blind placebo-controlled trial.

Setting: Inclusion at two neonatal intensive care units in Sweden. Local follow-up per national guidelines.

Subjects: 134 infants born at 23-27 weeks' gestation with a birth weight < 1000 g.

Intervention: Daily enteral supplementation with placebo or Limosilactobacillus reuteri DSM 17938 (2.5 × 108 colony forming units), from within 72 h after birth to postmenstrual week 35-36.

Main outcome measures: Bayley-III developmental assessment and auxology at 24 ± 3 months corrected age.

Results: Follow-up data were available for 110 of 117 surviving participants, and 85 children were assessed with Bayley-III. Mean language score after supplementation with L. reuteri was 90 (95% confidence interval: 85-95) compared to 83 in the placebo group (95% CI: 78-88), p = 0.04. No other significant differences in neurodevelopment or growth were observed.

Conclusion: Supplementation with L. reuteri in extremely preterm infants was not associated with altered growth nor general neurodevelopmental outcomes at 2 years while language index was improved. This is interesting given previously reported early improved growth of head circumference.

Keywords: growth; neonatology; neurodevelopment; preterm; probiotics.

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Conflict of interest statement

Thomas Abrahamsson has received honoraria for lectures and a study grant from BioGaia AB. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart for the PROPEL‐trial.
FIGURE 2
FIGURE 2
Neurodevelopmental impairment at 2 years corrected age for extremely preterm born children who received Limosilactobacillus reuteri DSM 17938 or placebo in the neonatal period. Ordinal regression analysis for testing of statistically significant difference.
FIGURE 3
FIGURE 3
Change in weight (A), length (B) and head circumference (C) in z‐score from birth to 28 days, to postmenstrual week (PMW) 36 + 0 and to two years corrected age respectively, in infants receiving Limosilactobacillus reuteri DSM 17938 (solid) and placebo (broken lines). z‐score calculated from standardised growth charts (18, 19). Error bars show 95% confidence intervals. **p < 0.01; t‐test for independent samples.
See this image and copyright information in PMC

References

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