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Prophylactic Probiotics in Premature Infants (C3P)

This study has been terminated.
(We are underpowered to find a difference in the primary outcome.)
Sponsor:
Collaborators:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Vanderbilt University
Information provided by:
Colombian Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT00727363
First received: July 31, 2008
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Death
Nosocomial Infection
Dietary Supplement: Lactobacillus reuteri
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prophylactic Probiotics for the Prevention of Sepsis and NEC in Premature Infants in Colombia. A Randomized Double-Blind, Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Colombian Neonatal Research Network:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Number of episodes of necrotizing enterocolitis experienced by each premature infant randomized to probiotic exposure or to placebo [ Time Frame: From birth to discharge from the NICU or death. Average time: 2 months ] [ Designated as safety issue: No ]
    Premature infants randomized to placebo or treatment within the first 48 hours of birth will be followed prospectively to determine number of necrotizing enterocolitis episodes experienced using a modification of Bells criteria for Stage 2.


Enrollment: 751
Study Start Date: August 2008
Estimated Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital. Patients fed through NG tube will be administered 5 drops of placebo through the NG tube followed by a 0.5 cc of a normal saline flush. Patients taking PO feeds will be administered 5 drops of placebo in posterior oropharynx after secretions have been suctioned.
Dietary Supplement: Placebo
5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.
Experimental: 2
5 drops of Lactobacillus reuteri DSM 17938 from an oil based suspension will be administered once a day until death or discharge home. Patients with NG feeds will be administered the probiotic in the amount of 5 drops through the NG tube followed by 0.5 cc of a normal saline flush. Patients with PO feeds will be administered 5 drops of the probiotics in the posterior oropharynx after secretions have been suctioned. If feeds are temporarily suspended because of feeding intolerance or NEC, the probiotic may be re-started once feeds are re-started.
Dietary Supplement: Lactobacillus reuteri
Lactobacillus reuteri DSM 17938 will be administered at a dose of ten to the eighth colony-forming units in 5 drops of a commercially available oil suspension once per day until discharge from the hospital.
Other Name: BioGaia Probiotic drops

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727363

Locations
Colombia
Hospital San Vicente de Paul
Medellin, Antioquia, Colombia
Hospital San Ignacio, Universidad Javeriana
Bogota, Cundinamarca, Colombia
Policlinico del Olaya
Bogota, Cundinamarca, Colombia
Clinica San Luis
Bucaramanga, Santander, Colombia
Hospital Universitario de Santander
Bucaramanga, Santander, Colombia
Clinica los Farallones
Cali, Valle, Colombia
Clinica Los Remedios
Cali, Valle, Colombia
Fundacion Valle de Lilli
Cali, Valle, Colombia
Sponsors and Collaborators
Colombian Neonatal Research Network
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Vanderbilt University
Investigators
Principal Investigator: Mario A Rojas, MD, MPH Vanderbilt University
Principal Investigator: Juan M Lozano, MD, Msc Universidad Javeriana
  More Information

No publications provided by Colombian Neonatal Research Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mario Augusto Rojas MD, MPH, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00727363     History of Changes
Other Study ID Numbers: CNRNProbiotics
Study First Received: July 31, 2008
Last Updated: June 21, 2011
Health Authority: Colombia: Institutional Review Board

Keywords provided by Colombian Neonatal Research Network:
probiotics
lactobacillus reuteri
preterm infants
nosocomial infection
necrotizing enterocolitis

Additional relevant MeSH terms:
Cross Infection
Infection

ClinicalTrials.gov processed this record on November 20, 2014