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

Phase 3

Completed

• Conditions: Nosocomial Infection; Necrotizing Enterocolitis
• Interventions: Biological: probiotics

• Registration Number: NCT01340469
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Status Verified: 2011-03
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-20
• Last Update Submitted: 2011-04-20
• Study First Posted: 2011-04-22
• Last Update Posted: 2011-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	probiotics	Probiotics supplementation .
control	probiotics	The control group received daily placebo liquid .

Primary Outcome Measures

Name	Time	Method
incidence of nosocomial infections	28 days or until discharge	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Chilalongkorn University; 🇹🇭 Bangkok, Thailand