Probiotic Supplementation in Extremely Preterm Infants in Scandinavia: A Double-blinded Randomized Controlled Multicenter Trial to Reduce the Risk of Necrotizing Enterocolitis and Mortality

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge. Patient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

• All extremly preterm infants born beween gestational age 22+0 to 27+6

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Solna
Contact Information
Primary
Alexander Rakow, MD PhD
alexander.rakow@regionstockholm.se
+46725968444
Backup
Sofia Söderquist-Kruth
sofia.soderquist-kruth@regionstockholm.se
+46738034038
Time Frame
Start Date: 2022-12-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1600
Treatments
Experimental: Probiotic group
Probiotic group: 0,5 g per day of ProPrems®, including a combination of Bifidobacterium infantis Bb-02 (DSM 33361) 300 million, Bifidobacterium lactis (BB-12®) 350 million and Streptococcus thermophilus (TH-4®) 350 million. Mixed with 3 mills of breastmilk
Placebo_comparator: Control group
Control group receives 3 mills of breastmilk without additives
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov

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