Prophylactic Probiotics in Premature Infants

NCT00727363 | Terminated Phase 3 DMC

• 1 other identifier: CNRNProbiotics
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 8

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.

Conditions

Death; Nosocomial Infection

Keywords

probiotics; lactobacillus reuteri; preterm infants; nosocomial infection; necrotizing enterocolitis

Outcome Measures

Primary Outcomes (1)

• Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants

  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.

  From birth to discharge from the NICU or death. Average time 2 months.

Secondary Outcomes (1)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

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

2

EXPERIMENTAL

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

Interventions

Lactobacillus reuteri DIETARY_SUPPLEMENT

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.

Also known as: BioGaia Probiotic drops

2

Placebo DIETARY_SUPPLEMENT

5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.

1

Eligibility Criteria

• Age: 1 Minute - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Admission to the NICU
• Written parental consent
• Birth weight \< 2000 grams
• Hemodynamically stable
• \< 48 hours of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Colombian Neonatal Research Network: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator
• Vanderbilt University: collaborator

Study Sites (8)

Hospital San Vicente de Paul

Medellín, Antioquia, Colombia

Location

Hospital San Ignacio, Universidad Javeriana

Bogota, Cundinamarca, Colombia

Location

Policlinico del Olaya

Bogota, Cundinamarca, Colombia

Location

Clinica San Luis

Bucaramanga, Santander Department, Colombia

Location

Hospital Universitario de Santander

Bucaramanga, Santander Department, Colombia

Location

Clinica los Farallones

Cali, Valle del Cauca Department, Colombia

Location

Clinica Los Remedios

Cali, Valle del Cauca Department, Colombia

Location

Fundacion Valle de Lilli

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (1)

• Rojas MA, Lozano JM, Rojas MX, Rodriguez VA, Rondon MA, Bastidas JA, Perez LA, Rojas C, Ovalle O, Garcia-Harker JE, Tamayo ME, Ruiz GC, Ballesteros A, Archila MM, Arevalo M. Prophylactic probiotics to prevent death and nosocomial infection in preterm infants. Pediatrics. 2012 Nov;130(5):e1113-20. doi: 10.1542/peds.2011-3584. Epub 2012 Oct 15.

  PMID: 23071204 DERIVED

MeSH Terms

Conditions

Death; Cross Infection; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Iatrogenic Disease; Disease Attributes; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Mario A Rojas, MD, MPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Juan M Lozano, MD, Msc

  Universidad Javeriana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 4, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

CO (8)