Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants

Nosocomial Infections and Necrotizing Enterocolitis in Preterm Neonates Treated With Lactobacillus Acidophilus and Bifidobacterium Infantis in An Intensive Care Unit : A Randomized Controlled Study

The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.

Study Overview

• Status: Completed
• Conditions: Necrotizing Enterocolitis; Nosocomial Infection
• Intervention / Treatment: Biological: probiotics

Detailed Description

There are growing numbers of evidence indicating the beneficial effects of normal enteric flora (probiotics) with regard to the host defense against infection. In vitro and in vivo studies have shown that probiotics such as lactobacilli and bifidobacteria have inhibitory effects on other pathogenic bacteria.This evidence, along with the results of recent clinical studies, has demonstrated the beneficial effects of probiotics in the prevention of NEC in VLBW infants.However, most of the studies reported nosocomial infection as a secondary outcome and the findings were controversial regarding probiotics efficacy in preventing nosocomial infections. There is only one study that was aimed to investigate effects of probiotic on the incidence of nosocomial infection.

Given the potential benefit of probiotics against infection and the lack of clinical studies in this regard, we conducted a randomized clinical trial to determine whether probiotic supplementation (in the form of Lactobacillus acidophilus and Bifidobacterium infantis) could reduce nosocomial infection rate among preterm VLBW infants in a intensive care nursery setting.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Faculty of Medicine Chilalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Very Low Birth Weight (VLBW) preterm infants (Gestational age < 35 weeks , BW < 1500 g ) admitted to the NICU who survived the first 3 days of life

Exclusion Criteria:

• Infants with chromosome abnormality or severe congenital defects, especially gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction) and infants with unstable hemodynamic status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study; Probiotics supplementation .	Biological: probiotics; Daily enteral probiotic supplementation (live Lactobacillus acidophilus and Bifidobacterium infantis) at a dose of 2.5 x 108 CFU of each strain once a day.The supplementation was started on the first day of enteral feeding and continued for at least 28 days or until discharge. The study drug was in liquid form and mixed with breast milk or formula before given to the infants. The preparation was made on a daily basis by one person who was not involved in the care of the infants.; Other Names: Infloran (Swiss Berna)
Placebo Comparator: control; The control group received daily placebo liquid .	Biological: probiotics; Daily enteral probiotic supplementation (live Lactobacillus acidophilus and Bifidobacterium infantis) at a dose of 2.5 x 108 CFU of each strain once a day.The supplementation was started on the first day of enteral feeding and continued for at least 28 days or until discharge. The study drug was in liquid form and mixed with breast milk or formula before given to the infants. The preparation was made on a daily basis by one person who was not involved in the care of the infants.; Other Names: Infloran (Swiss Berna)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of nosocomial infections	Nosocomial infections , defined as any major infection occurring during the hospitalization, not earlier than 5 days of life.(sepsis, pneumonia, NEC, meningitis, omphalitis, osteomyelitis, soft tissue infection etc.). Sepsis was defined as a clinical syndrome of systemic illness accompanied by positive blood culture.	28 days or until discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of necrotizing enterocolitis (NEC)	necrotizing enterocolitis (NEC), which was identified and categorized by modified Bell's classification	28 days or until discharge
feeding tolerance	the volume of feeding on day 7,14,21, and 28 of study	28 days
time to full enteral feeding	time required to reach full feeding at 150 ml/kg/day	28 days

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Santi Punnahitananda, M.D., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: April 20, 2011
• First Posted (Estimate): April 22, 2011

Study Record Updates

• Last Update Posted (Estimate): April 22, 2011
• Last Update Submitted That Met QC Criteria: April 20, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: probiotics; preterm infants; necrotizing enterocolitis; nosocomial infections; ver low birth weight
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Body Weight; Gastroenteritis; Intestinal Diseases; Iatrogenic Disease; Infections; Communicable Diseases; Birth Weight; Enterocolitis; Enterocolitis, Necrotizing; Cross Infection
• Other Study ID Numbers: 076/2003