Status:
TERMINATED
Prophylactic Probiotics in Premature Infants
Lead Sponsor:
Colombian Neonatal Research Network
Collaborating Sponsors:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Vanderbilt University
Conditions:
Death
Nosocomial Infection
Eligibility:
All Genders
1-48 years
Phase:
PHASE3
Brief Summary
This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the...
Detailed Description
Neonatal infections currently cause about 1.6 million deaths annually in developing countries. Preterm infants are especially vulnerable to infections because of their immature immune responses and th...
Eligibility Criteria
Inclusion
- Admission to the NICU
- Written parental consent
- Birth weight \< 2000 grams
- Hemodynamically stable
- \< 48 hours of age
Exclusion
- Evidence or suspicion of congenital intestinal obstruction or perforation
- Prenatal or postnatal diagnosis of gastroschisis, large omphalocele, or congenital diaphragmatic hernia
- Major congenital heart defects
- Anticipated transfer to a NICU not involved in the study
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT00727363
Start Date
August 1 2008
End Date
August 1 2011
Last Update
June 22 2011
Active Locations (8)
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1
Hospital San Vicente de Paul
Medellín, Antioquia, Colombia
2
Hospital San Ignacio, Universidad Javeriana
Bogota, Cundinamarca, Colombia
3
Policlinico del Olaya
Bogota, Cundinamarca, Colombia
4
Clinica San Luis
Bucaramanga, Santander Department, Colombia