Actively Recruiting
Led by Region Stockholm · Updated on 2023-10-16
1600
Participants Needed
1
Research Sites
30 weeks
Total Duration
Researchers are evaluating whether giving probiotics to extremely preterm infants born before 28 weeks of gestation can reduce the risk of necrotizing enterocolitis (NEC), a serious intestinal disease, and neonatal death. This study is a double-blinded, randomized controlled trial involving 1620 extremely preterm infants at neonatal intensive care units in Sweden and Denmark. The goal is to provide evidence on the safety and effects of probiotic supplementation in this vulnerable group, which currently is not covered by clinical guidelines due to limited data. Infants who tolerate at least 3 mL of breastmilk per feeding will receive a daily probiotic supplement called ProPrems®, which contains specific strains of beneficial bacteria mixed with breastmilk. This treatment will continue until the infant reaches 34 weeks of gestational age. The control group will receive breastmilk alone without the probiotic supplement. The study is carefully blinded so that medical staff and researchers do not know which infants receive probiotics, ensuring unbiased results. During the study, infants will be monitored for NEC and mortality up to 34 weeks gestational age plus 2 weeks, with secondary measures including sepsis, antibiotic use, hospital stay length, feeding tolerance, growth, and body composition after hospital discharge. Researchers will also collect stool samples to analyze gut microbiome development at multiple timepoints up to 12 months corrected age. Participation involves regular clinical assessments and data collection from medical records and neonatal quality registers, supporting a comprehensive evaluation of probiotic supplementation effects in extremely preterm infants.
CONDITIONS
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - Up to 72 hours after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 8 to 14 weeks depending on gestational age at birth
Participants receive daily probiotic supplementation mixed with breastmilk or breastmilk alone via gastric tube starting when they tolerate at least 3 mL of breastmilk per meal until 34 weeks of gestational age.
Daily administration during hospital stay with ongoing clinical assessments
Duration - Up to 12 months corrected age after end of treatment
Participants are monitored for outcomes including feeding tolerance, growth, gut microbiome development, and survival up to 12 months corrected age.
Scheduled visits at 40 weeks gestational age, 12 months corrected age, and additional assessments during hospitalization
Total: 1 location
1
Karolinska University Hospital
Solna, Stockholm County, Sweden, 17176
Actively Recruiting
A
Alexander Rakow, MD PhD
S
Sofia Söderquist-Kruth
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Sofia Söderquist Kruth, Carl Willers, Emma Persad...
https://pubmed.ncbi.nlm.nih.gov/38610034