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

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340469
• Other study ID #: 076/2003
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2011
• Last updated: April 20, 2011
• Start date: January 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2011
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Enterocolitis
• Enterocolitis, Necrotizing
• Infection
• Necrotizing Enterocolitis
• Nosocomial Infection

Intervention

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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Chilalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	incidence of necrotizing enterocolitis (NEC)	necrotizing enterocolitis (NEC), which was identified and categorized by modified Bell's classification	28 days or until discharge	No
Secondary	feeding tolerance	the volume of feeding on day 7,14,21, and 28 of study	28 days	No
Secondary	time to full enteral feeding	time required to reach full feeding at 150 ml/kg/day	28 days	No