Effect of oral probiotic supplementation on the rate of hospital acquired infection and necrotizing enterocolitis in preterm very low birth weight infants

ISRCTN ISRCTN39142169
DOI https://doi.org/10.1186/ISRCTN39142169
Secondary identifying numbers N/A
Submission date
18/04/2011
Registration date
28/04/2011
Last edited
28/04/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Santi Punnahitananda
Scientific

Department of Pediatrics
Faculty of Medicine, Chulalongkorn University
Rama IV Road
Pathumwan
Bangkok
10330
Thailand

Email santi.p@chula.ac.th

Study information

Study designRandomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleNosocomial 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
Study objectivesDaily 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(s)Ethical Committee of the Institutional Review Board of the Faculty of Medicine, Chilalongkorn University approved on 28th February 2003, Ref: 065/2003
Health condition(s) or problem(s) studiedHospital acquired infection and necrotizing enterocolitis in neonates
InterventionDaily 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 typeOther
Primary outcome measureNosocomial Infections
Secondary outcome measures1. Necrotizing enterocolitis (NEC)
2. Feeding tolerance
3. Time to reach full enteral feeding
Overall study start date01/01/2005
Completion date31/03/2008

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants160
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2005
Date of final enrolment31/03/2008

Locations

Countries of recruitment

  • Thailand

Study participating centre

Department of Pediatrics
Bangkok
10330
Thailand

Sponsor information

Faculty of Medicine Chulalongkorn University (Thailand)
University/education

Rama IV Road
Pathumwan
Bangkok
10330
Thailand

Email grad@chula.ac.th
ROR logo "ROR" https://ror.org/028wp3y58

Funders

Funder type

University/education

Faculty of Medicine Chulalongkorn University (Thailand)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan