Status:
TERMINATED
Effects of Lactobacillus Reuteri in Premature Infants
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Pontificia Universidad Catolica de Chile
Conditions:
Premature Infant Disease
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobaci...
Detailed Description
The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, o...
Eligibility Criteria
Inclusion
- Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days
Exclusion
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
- Parental refusal
- Prior enrollment into a conflicting clinical trial
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01181791
Start Date
July 1 2010
End Date
July 1 2017
Last Update
August 28 2017
Active Locations (2)
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1
Hospital Sotero del Rio
Santiago, Chile
2
Pontifica Universidad Catolica
Santiago, Chile