Prophylactic Probiotics in Premature Infants - Full Text View

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 III

MedlinePlus related topics:

Dietary Supplements Premature Babies Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title:	Prophylactic Probiotics for the Prevention of Sepsis and NEC in Premature Infants in Colombia. A Randomized Double-Blind, Multicenter Trial

Further study details as provided by Colombian Neonatal Research Network:

Primary Outcome Measures:

Prevention of death or nosocomial sepsis in preterm infants [ Time Frame: At discharge from the NICU ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

necrotizing enterocolitis [ Time Frame: At discharge from the NICU ] [ Designated as safety issue: No ]

Estimated Enrollment:	1110
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.	Dietary Supplement: Placebo 5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.
2: Experimental L reuteri DSM 17938	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.

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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

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

Contacts


Contact: Juan M Lozano, MD, Msc	0115713208320 ext 2801	jmlozano@javeriana.edu.co

Contact: Maria X Rojas, RN, Msc	0115713208320 ext 2811	mxrojas@javeriana.edu.co

Locations


Colombia, Antioquia
	Hospital San Vicente de Paul	Not yet recruiting
	Medellin, Antioquia, Colombia
	Principal Investigator: Maria E Tamayo, MD

Colombia, Cundinamarca
	Hospital San Ignacio, Universidad Javeriana	Not yet recruiting
	Bogota, Cundinamarca, Colombia
	Sub-Investigator: Maria X Rojas, RN, Msc
	Principal Investigator: Gloria Ruiz, MD
	Policlinico del Olaya	Not yet recruiting
	Bogota, Cundinamarca, Colombia
	Principal Investigator: Catherine Rojas, MD

Colombia, Santander
	Hospital Universitario de Santander	Not yet recruiting
	Bucaramanga, Santander, Colombia
	Principal Investigator: Luis A Perez, MD
	Clinica San Luis	Not yet recruiting
	Bucaramanga, Santander, Colombia
	Principal Investigator: Jorge E Garcia-Harker, MD

Colombia, Valle
	Fundacion Valle de Lilli	Not yet recruiting
	Cali, Valle, Colombia
	Principal Investigator: Adriana Ballesteros, MD
	Clinica los Farallones	Not yet recruiting
	Cali, Valle, Colombia
	Principal Investigator: Jaime A Bastidas, MD
	Clinica Los Remedios	Not yet recruiting
	Cali, Valle, Colombia
	Principal Investigator: Mauricio Arevalo, MD

Sponsors and Collaborators

Colombian Neonatal Research Network

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Vanderbilt University

Investigators


Study Director:	Mario A Rojas, MD, MPH	Vanderbilt University

Principal Investigator:	Juan M Lozano, MD, Msc	Universidad Javeriana

More Information

Responsible Party:	Universidad Javeriana ( Juan M Lozano MD, Msc. )
Study ID Numbers:	CNRNProbiotics
First Received:	July 31, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00727363
Health Authority:	Colombia: Institutional Review Board

Keywords provided by Colombian Neonatal Research Network:

probiotics

lactobacillus reuteri

preterm infants

nosocomial infection

necrotizing enterocolitis

Study placed in the following topic categories:

Death

Sepsis

Necrotizing enterocolitis

Enterocolitis, Necrotizing

Enterocolitis

Cross Infection

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Colombian Neonatal Research Network 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