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Active Not Recruiting
NCT01603368
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Conditions: Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis, Neuro Developmental Delay, Asthma (Diagnosis), Lung Function, Fitness
Sex: All
Ages: 1 Day – 3 Days
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 134
Sponsor: Ostergotland County Council, Sweden
Location: Crown Princess Victoria Chilkdren´s Hopstial, University Hospital Linköping
Summary
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition.
The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Follow ups will be conducted at 2. 5,5- and 14 years of age for evaluating neurodevelopment, lung function and physical fitness. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.
Eligibility Criteria
Inclusion Criteria:
* Birth weight \< 1000 g
* Gestational age: v23+0-V27 +6.
* Age \< 72 hours at inclusion.
* Signed informed consent by parents.
Exclusion Criteria:
* Fatal or complex congenital malformation at inclusion time.
* Chromosomal defect at inclusion time.
* No realistic hope of survival at inclusion time.
* Gastrointestinal malformation at inclusion time.
* Participation in another study which aims to influence nutrition, growth, feeding tolerance or necrotizing enterocolitis.
Source: ClinicalTrials.gov (NCT01603368). StuddyBuddy aggregates publicly available trial information.