Effect of oral probiotic supplementation on the rate of hospital acquired infection and necrotizing enterocolitis in preterm very low birth weight infants
ISRCTN | ISRCTN39142169 |
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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
Scientific
Department of Pediatrics
Faculty of Medicine, Chulalongkorn University
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
santi.p@chula.ac.th |
Study information
Study design | Randomized controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | Nosocomial Infections |
Secondary outcome measures | 1. Necrotizing enterocolitis (NEC) 2. Feeding tolerance 3. Time to reach full enteral feeding |
Overall study start date | 01/01/2005 |
Completion date | 31/03/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 160 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2005 |
Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Pediatrics
Bangkok
10330
Thailand
10330
Thailand
Sponsor information
Faculty of Medicine Chulalongkorn University (Thailand)
University/education
University/education
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
grad@chula.ac.th | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |