Prophylactic Probiotics for the Prevention of Sepsis and NEC in Premature Infants in Colombia. A Randomized Double-Blind, Multicenter Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 751
- Locations
- 8
- Primary Endpoint
- Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants
Study Overview
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 development of a severe inflammatory disease of the bowel called necrotizing enterocolitis. The investigators propose that premature infants not given probiotics will colonize their gut with bad bacterias and develop infection.
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 their exposure to the hospital milieu which promotes gastrointestinal colonization with Gram-negative pathogens. Multiple studies have shown that the colonization of the bowel with probiotics (nonpathogenic anaerobic bacteria) competitively inhibit the attachment of Gram-negative pathogens decreasing their likelihood for bacterial translocation and the development of life threatening infections.This potentially high-impact, low-cost intervention may significantly improve the survival and morbidity of preterm infants around the world.
RESEARCH OBJECTIVE
We seek to determine whether prophylactic administration of Lactobacillus reuteri decreases the incidence of death and nosocomial sepsis among susceptible preterm infants in a neonatal care setting in Colombia.
Specific aims:
- To investigate the efficacy and safety of oral Lactobacillus reuteri for the primary endpoint prevention of death or nosocomial sepsis in preterm infants through a well powered multicenter, randomized, double-blinded, placebo-controlled clinical trial (RCT).
- To assess the impact of Lactobacillus reuteri on four secondary endpoints: necrotizing enterocolitis, prevalence of Gram-negative pathogens, duration of hospitalization, and frequency of outpatient treatment and re-admission for infectious causes at 6 months post-discharge.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Minute to 48 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Admission to the NICU
- •Written parental consent
- •Birth weight < 2000 grams
- •Hemodynamically stable
- •< 48 hours of age
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants
Time Frame: From birth to discharge from the NICU or death. Average time 2 months.
Premature infants randomized within the first 48 hours of birth will be followed prospectively to determine number of deaths and episodes of nosocomial sepsis between placebo and control groups.
Secondary Outcomes
- Number of episodes of necrotizing enterocolitis experienced by each premature infant randomized to probiotic exposure or to placebo(From birth to discharge from the NICU or death. Average time: 2 months)