Clinical trial NCT01340469: Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nosocomial Infection
Necrotizing Enterocolitis
Keywords: nosocomial infections
necrotizing enterocolitis
preterm infants
ver low birth weight
probiotics
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of nosocomial infections
timeFrame: 28 days or until discharge
Secondary outcomes:
measure: incidence of necrotizing enterocolitis (NEC)
timeFrame: 28 days or until discharge
measure: feeding tolerance
timeFrame: 28 days
measure: time to full enteral feeding
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Chilalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Santi Punnahitananda, M.D.
role: PRINCIPAL_INVESTIGATOR
References: