Probiotic supplementation for extremely preterm infants in Scandinavia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate the effectiveness of probiotic supplementation in reducing the risk of necrotizing enterocolitis (NEC) and neonatal mortality among extremely preterm infants born before 28 weeks of gestation. The study involves a double-blinded, multicenter randomized controlled trial with 1620 participants across six neonatal units in Sweden and four in Denmark. Infants in the intervention group will receive a specific probiotic combination mixed with breastmilk, while the control group will receive breastmilk without probiotics. The primary outcome will assess the incidence of NEC and mortality, with secondary outcomes focusing on other neonatal morbidities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Karolinska University Hospital
  Solna, Stockholm County, Sweden Recruiting

Study contacts

• Study coordinator: Alexander Rakow, MD PhD
• Email: alexander.rakow@regionstockholm.se
• Phone: +46725968444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.