Objective:The goal of this study was to investigate the efficacy of Saccharomyces boulardii in the treatment of neonatal hyperbilirubinemi in late preterms and term neonates. Design: A prospective, double blinded, randomized, placebo controlled trial. Setting: Single center in Istanbul, Turkey. Patients: Late preterm (34, not completed week – 36, completed gestational weeks) and term (≥ 37 gestational weeks) neonates who need phototherapy for neonatal hyperbilirubinemia Interventions: Neonates were randomized either to receive probiotic (Saccharomyces boulardii 50 mg/kg every 12 hours) or placebo during phototherapy. Main outcome measures: Phototherapy duration, maximum bilirubine level
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123010279N2
Registration date:2013-01-12, 1391/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-12, 1391/10/23
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
2012-07-20, 1391/04/30
Expected recruitment end date
2013-08-30, 1392/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficiency of Saccharomyces boulardii on neonatal hyperbilirubinemia with placebo on late pereterm and term neonates
Public title
Saccharomyces boulardii's efficiency on hyperbilirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Late preterm (34, not completed week – 36, completed week) gestational weeks ) and term (≥ 37 gestational weeks) neonates
2. Newborns who need phototherapy for neonatal hyperbilirubinemia
3. Newborns who were 0-1 month old.
Exclusion criteria:
1. Newborns who have congenital anomalies
2. Newborns who need intense phototherapy
3. Direct coombs positive ABO/Rh incompatability
4. Neonates who have sepsis/pneumonia during phototherapy
5. Neonates with hypothyroidism
6. Neonates who have gastrointestinal obstruction
7. Neonates with asphyxia
8. Contraindication of peroral feeding
Age
To 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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. One nurse who was not involved in the care of the infants prepared Saccharomyces boulardii or distilled water. She gave the prepared material without label to the nurse who was responsible for the infant’s care. The first investigator who randomized patients and ordered supplementation to the first 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 first nurse, who were not involved in the care of the study infants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zeynep Kamil Maternity and Children Education and Training Hospital Ethic Commitee