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

  • 2025-02-13
  • Acta paediatrica (Oslo, Norway : 1992) 114(8)
    • Erik Wejryd
    • Giovanna Marchini
    • Peter Bang
    • Baldvin Jonsson
    • Ulrika Ådén
    • Thomas Abrahamsson

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 134
Population
134 infants born at 23-27 weeks' gestation with a birth weight < 1000 g
Methods
Randomised double-blind placebo-controlled trial; daily enteral supplementation with placebo or Limosilactobacillus reuteri DSM 17938 (2.5 × 10^8 colony forming units), from within 72 h after birth to postmenstrual week 35-36
Blinding
Double-blind
Duration
from within 72 h after birth to postmenstrual week 35-36
Funding
Unclear
  • Large Human Trial

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.

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