Probiotic supplementation for extremely preterm infants in Scandinavia
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia: A Double-blinded Randomized Controlled Multicenter Trial to Reduce the Risk of Necrotizing Enterocolitis and Mortality
This study is testing if giving probiotics mixed with breastmilk can help extremely preterm infants avoid serious gut problems and reduce the risk of dying.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 22 Weeks to 28 Weeks |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Solna, Stockholm County) |
| Trial ID | NCT05604846 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are extremely preterm infants born between gestational ages 22+0 to 27+6 weeks.
Not a fit: Patients with severe complications detected within the first 72 hours of life or major congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of NEC and neonatal mortality in extremely preterm infants.
How similar studies have performed: Previous studies have shown reduced incidence of NEC in preterm infants, but this specific approach for extremely preterm infants is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Solna, Stockholm County
- Karolinska University Hospital — Solna, Stockholm County, Sweden (Recruiting)
Study contacts
- Study coordinator: Alexander Rakow, MD PhD
- Email: alexander.rakow@regionstockholm.se
- Phone: +46725968444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.