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Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

RecruitingNAAges 22 Weeks - 28 WeeksAllRegion Stockholm
NCT05604846 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28. P: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark. I: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34. C: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily. O: Primary outcome variables

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📋 Eligibility rules (as published)
Inclusion Criteria: -All extremly preterm infants born beween gestational age 22+0 to 27+6 Exclusion Criteria: * Patients with severe complications and low chance of survival detected wihin the first 72 hours of life * Patients with major congenital-anomalies * Patients included in other interventional trials with the same or overlapping oucome measures.
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What it tests

  • ProPrems
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Where

1 site
Karolinska University Hospital
Solna, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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