Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
Launched by REGION STOCKHOLM · Oct 30, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether giving probiotics, which are beneficial bacteria, to extremely preterm infants (those born before 28 weeks of pregnancy) can help reduce the risk of serious health problems like necrotizing enterocolitis (a dangerous intestinal condition) and improve survival rates. The trial involves 1,620 infants from several hospitals in Sweden and Denmark. Some babies will receive a daily probiotic mixed with breast milk, while others will receive breast milk without the probiotics. Researchers will monitor how these infants do in terms of health outcomes, hospital stay duration, and overall growth.
To be eligible for this trial, infants must be born between 22 to 27 weeks of pregnancy. However, those with severe health issues or major birth defects, as well as those already participating in similar studies, cannot join. The goal of this research is to provide evidence on the safety and effectiveness of probiotics for very preterm babies, which could lead to better care practices, shorter hospital stays, and improved health outcomes for these vulnerable infants.
Gender
ALL
Eligibility 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.
About Region Stockholm
Region Stockholm is a leading healthcare authority committed to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, Region Stockholm collaborates with hospitals, research institutions, and industry partners to facilitate the development of new therapies and treatment protocols. With a focus on quality, safety, and ethical standards, the organization aims to enhance health outcomes for the diverse population of Stockholm and beyond, leveraging cutting-edge research to translate scientific discoveries into effective healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Solna, Stockholm, Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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