Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus reuteri (biogai AB, Sweden)

Dietary Supplement

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.

Primary outcomes

The use of probiotics in newborn preterm infants receiving antibiotics will be investigated type of resistant microorganisms in the flora of intestinal and nasal.

Time frame: Up to 12 month

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.

Secondary outcomes

Types Of Resistant Microorganisms In The Culture

Time frame: Up to 12 month

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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 30, 2014
Registry last updated: Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed