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

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ClinicalTrials.gov Identifier: NCT01340469
Recruitment Status : Completed
First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Nosocomial Infection Necrotizing Enterocolitis Biological: probiotics Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

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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 Name: 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 Name: Infloran (Swiss Berna)




Primary Outcome Measures :
  1. incidence of nosocomial infections [ Time Frame: 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 :
  1. incidence of necrotizing enterocolitis (NEC) [ Time Frame: 28 days or until discharge ]
    necrotizing enterocolitis (NEC), which was identified and categorized by modified Bell's classification

  2. feeding tolerance [ Time Frame: 28 days ]
    the volume of feeding on day 7,14,21, and 28 of study

  3. time to full enteral feeding [ Time Frame: 28 days ]
    time required to reach full feeding at 150 ml/kg/day



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340469


Locations
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Thailand
Faculty of Medicine Chilalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
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Principal Investigator: Santi Punnahitananda, M.D. Chulalongkorn University

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Responsible Party: Santi Punnahitananda, Faculty of Medicine Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01340469     History of Changes
Other Study ID Numbers: 076/2003
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: March 2011
Keywords provided by King Chulalongkorn Memorial Hospital:
nosocomial infections
necrotizing enterocolitis
preterm infants
ver low birth weight
probiotics
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Enterocolitis
Enterocolitis, Necrotizing
Birth Weight
Body Weight
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes