Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

Effect Of Probiotics On Resistant Bacteria Colonization Preterm Newborn Infants Receiving Antibiotics In Neonatal Intensive Care Unit

In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the use of probiotics in preterm neonates in neonatal intensive care units expect to prevent colonization by resistant microorganisms.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri (biogai AB, Sweden)

Detailed Description

The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and prevent colonization with pathogenic microorganisms of the intestines . In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The study were included ≤36 weeks gestational age newborn preterm infants requiring antibiotic treatment and/or prophylaxis.

Exclusion Criteria:

• Newborn preterm infants who are congenital anomalies and not require antibiotic therapy and undergoing intestinal operation were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lactobacillus reuteri; The study was performed by two groups. And these groups were constituted from the newborn preterm infants who are received probiotics (Lactobacillus reuteri) and no probiotics.

Dietary supplement: Lactobacillus reuteri (biogai AB, Sweden); Lactobacillus reuteri (biogai AB, Sweden) was given to probiotic group, same way to all newborn newborn preterm infants, directly oral feeding and without any along with a mixture, admission following the in nicu, as a daily dose 1x108 cfu / day (1x5 drops / day) during hospitalization; Other Names: Probiotics were randomly given to newborn preterm infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The use of probiotics in newborn preterm infants receiving antibiotics will be investigated type of resistant microorganisms in the flora of intestinal and nasal.	The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and to prevent colonization with pathogenic microorganisms of the intestines . In this study, we investigated the effect use of probiotic on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.	Up to 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types Of Resistant Microorganisms In The Culture	In the culture, all possible resistant microorganisms such as methicillin-resistant Staphylococci aureus, Enterococcus, Klebsiella spp, Escherichia coli, Pseudomonas aeruginosa, Enterobacter, Acinetobacter, Serratia, Candida species were investigated.	Up to 12 month

Collaborators and Investigators

• Sponsor: Baskent University
• Investigators: Principal Investigator: Abdullah Kurt, Neonatology, Başkent University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Newborn, preterm, probiotic, resistant microorganisms
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: Kurt - 1