Objective: The efficacy and safety of probiotics are controversial in preterm infants. They have strain specific effects and the effects of fungi have been investigated poorly. The goal of this study was to investigate the efficacy of Saccharomyces boulardii in preventing necrotizing enterocolitis and sepsis in very low birth weight infants.
Design: A prospective, double blinded, randomized, placebo controlled trial.
Setting: Single center in Istanbul, Turkey.
Patients: Infants were born ≤32 gestational age, ≤1500 g birth weight.
Interventions: Very low birth weight infants who started enteral feeding were randomized either to receive daily feeding supplementation with probiotic (Saccharomyces boulardii 50 mg/kg every 12 hours) or placebo until discharge.
Main outcome measures: Necrotizing enterocolitis (Bell’s stage ≥2) and sepsis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071410279N1
Registration date:2012-10-19, 1391/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-19, 1391/07/28
Registrant information
Name
Ozge Serce Pehlevan
Name of organization / entity
Zeynep Kamil Maternity and Children Education and Training Hospital
Country
Turkey
Phone
08 60 193 612 0900
Email address
ozge.serce@marmara.edu.tr
Recruitment status
Recruitment complete
Funding source
Drug was insured from Biocodex.
Expected recruitment start date
2010-10-01, 1389/07/09
Expected recruitment end date
2011-11-30, 1390/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylaxis effect of Saccharomyces boulardii on necrotizing enterocolitis with placebo on very low birth weight infants
Public title
Outcome of Saccharomyces boulardii prophlaxis on necrotizing enterocolitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Very low birth weight infants (gestational age: ≤32 weeks; birth weight: ≤1500 g) who survived to feed enterally (minimum age: first postnatal day, maximum age: 1 week).
Exclusion criteria: Infants who had severe asphyxia (stage III), major congenital anomalies, those who had been fasted for more than 3 weeks, died within the first postnatal 14 days and infants who used antifungal therapy were excluded.
Age
To 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
208
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients were assigned randomly to the study or control group by the principal investigator. Randomization was performed by using sequential numbers generated at the computer center. Feeding nurse who was not involved in the care of the infants added Saccharomyces boulardii to the feeding. She gave the feeding without label to the nurse who was responsible from the infant’s care. The first investigator who randomized patients and ordered supplementation to the feeding nurse gave just only the patients name to the second investigator for follow-up. Therefore, the only personnel who knew the infants’ group assignments were the first investigator and the feeding nurse, who were not involved in the care of the study infants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Health Ministry Drug and Pharmacy General Management
Street address
Söğütözü Mahallesi 2176. Sokak No:5
City
ANKARA
Postal code
06520
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
08
Health conditions studied
1
Description of health condition studied
Necrotizing eneterocolitis, neonatal sepsis
ICD-10 code
P77, P36
ICD-10 code description
Necrotizing enterocolitis of fetus and newborn, bacterial sepsis of newborn
Primary outcomes
1
Description
Sepsis
Timepoint
Starts at the same time with the intervention
Method of measurement
Patients' medical records
2
Description
Necrotizing enterocolitis
Timepoint
Starts at the same time with the intervention
Method of measurement
Patients' medical records
Secondary outcomes
1
Description
Length of hospitalization
Timepoint
Starts at the same time with the intervention
Method of measurement
Patients' medical records
2
Description
Time to reach full enteral feeding
Timepoint
Starts at the same time with the intervention
Method of measurement
Patients medical records
3
Description
Mortality until hospital discharge
Timepoint
Starts at the same time with the intervention
Method of measurement
Patients' medical records
4
Description
Weight gain per week
Timepoint
Starts on the 7th day of intervention
Method of measurement
Patients' medical records
5
Description
Neurocognitive development
Timepoint
18 months corrected age
Method of measurement
Bayley test
Intervention groups
1
Description
The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) which were added to breast milk or formula until discharge.
Category
Treatment - Drugs
2
Description
The control group received placebo (distilled water; 1 cc per dose twice daily) which were added to breast milk or formula until discharge.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeynep Kamil Maternity and Children Education and Training Hospital