Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

Infant, Premature, Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178267
• Other study ID #: Kurt - 1
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: June 27, 2014
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2014
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No