Contact information
Type
Scientific
Primary contact
Dr Santi Punnahitananda
ORCID ID
Contact details
Department of Pediatrics
Faculty of Medicine
Chulalongkorn University
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
santi.p@chula.ac.th
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Nosocomial infections and necrotizing enterocolitis in preterm very low birth weight neonates treated with lactobacillus acidophilus and bifidobacterium infantis in an intensive care unit : a randomized controlled study
Acronym
Study hypothesis
Daily enteral probiotics supplementation can reduce nosocomial infections and necrotizing enterocolitis (NEC) among very low birth weight (VLBW) infants in a neonatal intensive care unit
Ethics approval
Ethical Committee of the Institutional Review Board of the Faculty of Medicine, Chilalongkorn University approved on 28th February 2003, Ref: 065/2003
Study design
Randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hospital acquired infection and necrotizing enterocolitis in neonates
Intervention
Daily enteral probiotic supplementation of live Lactobacillus acidophilus and Bifidobacterium infantis at a dose of 2.5 x 108 CFU of each strain once a day for at least 28 days versus placebo
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Nosocomial Infections
Secondary outcome measures
1. Necrotizing enterocolitis (NEC)
2. Feeding tolerance
3. Time to reach full enteral feeding
Overall trial start date
01/01/2005
Overall trial end date
31/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. VLBW preterm infants (gestational age (GA) < 35 weeks , body weight (BW) < 1.5 kg)
2. Admitted to the neonatal intensive care unit (NICU) who survived the first 3 days of life
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
160
Participant exclusion criteria
1. Infants with chromosome abnormality
2. Infants with severe congenital defects
3. Infants with gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction)
4. Infants with unstable hemodynamic status
Recruitment start date
01/01/2005
Recruitment end date
31/03/2008
Locations
Countries of recruitment
Thailand
Trial participating centre
Department of Pediatrics
Bangkok
10330
Thailand
Sponsor information
Organisation
Faculty of Medicine Chulalongkorn University (Thailand)
Sponsor details
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
grad@chula.ac.th
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Faculty of Medicine Chulalongkorn University (Thailand)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary