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Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

NCT05604846 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2023-10-16

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis
  • Death
  • Sepsis Newborn
  • Feeding Disorder Neonatal
  • Growth Acceleration

Interventions

DIETARY_SUPPLEMENT

ProPrems

The intervention product, commercially known as ProPrems®, is a combination of (one billion freeze-dried bacteria per 0.5 g in a maltodextrin base powder: Bifidobacterium infantis Bb-02 (DSM 33361) 300 million, Bifidobacterium lactis (BB-12®) 350 million, and Streptococcus thermophilus (TH-4®) 350 million will be given daily once to eligable infants born extremly preterm (\<28weeks of gestation) once they tolerate 3ml of enterla feeds until the age of 34 weeks of gestation.

Sponsors & Collaborators

  • Region Stockholm

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604846 on ClinicalTrials.gov