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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01340469
Other study ID # 076/2003
Secondary ID
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


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
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