Condition category
Infections and Infestations
Date applied
18/04/2011
Date assigned
28/04/2011
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes