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Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants

Primary Purpose

Indirect Hyperbilirubinemia

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Reflor
serum physiologic
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Indirect Hyperbilirubinemia focused on measuring indirect hyperbilirubinemia, very low birth weight infants

Eligibility Criteria

1 Day - 15 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • very low birth weight infants

Exclusion Criteria:

  • chromosomal anomalies

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching Hospital, Division of NeonatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Saccharomyces boulardii

placebo

Arm Description

study group

serum physiologic

Outcomes

Primary Outcome Measures

Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration

Secondary Outcome Measures

long term effect of S.boulardii on neurodevelopmental outcome

Full Information

First Posted
August 5, 2011
Last Updated
August 5, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01411761
Brief Title
Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants
Official Title
Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indirect Hyperbilirubinemia
Keywords
indirect hyperbilirubinemia, very low birth weight infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saccharomyces boulardii
Arm Type
Experimental
Arm Description
study group
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
serum physiologic
Intervention Type
Dietary Supplement
Intervention Name(s)
Reflor
Intervention Description
5 million unit/day, first 15 day of life
Intervention Type
Other
Intervention Name(s)
serum physiologic
Intervention Description
1 cc added to one feeding in a day
Primary Outcome Measure Information:
Title
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration
Time Frame
6 months
Secondary Outcome Measure Information:
Title
long term effect of S.boulardii on neurodevelopmental outcome
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
15 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: very low birth weight infants Exclusion Criteria: chromosomal anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze Demirel, MD
Phone
+905324540156
Email
kgamze@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ugur Dilmen, Prof
Organizational Affiliation
Zekai Tahir Burak Maternit Teaching Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Phone
+905324540156
Email
kgamze@hotmail.com
First Name & Middle Initial & Last Name & Degree
Omer Erdeve, Assoc Prof
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD

12. IPD Sharing Statement

Learn more about this trial

Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants

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