Status:
COMPLETED
A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
Lead Sponsor:
Lingfen Xu, MD
Conditions:
Infant, Premature, Diseases
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE3
Brief Summary
Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of probiotics on growth and...
Detailed Description
The objective of this study is to evaluate if feeding supplemented with S. boulardii can improve growth and clinical outcomes in preterm and low birth weight infants. A prospective, randomized case-c...
Eligibility Criteria
Inclusion
- The inclusion criteria were hospital born infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g.
Exclusion
- Exclusion criteria were severe neonatal pathology such as birth complications, GI malformations, chromosomal abnormalities, known immunodeficiency, hydrops foetalis, a central venous catheter and the use of antifungal drugs or probiotics.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT02310425
Start Date
March 1 2013
End Date
January 1 2014
Last Update
December 8 2014
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