Back to results

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

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

NCT ID

NCT01411761

First Posted

August 5, 2011

Last Updated

August 5, 2011

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

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

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

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

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

We'll reach out to this number within 24 hrs