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Bifidobacterium Supplementation for Very Low Birth Weight Infants (Bifido(RCT))

Primary Purpose

Preterm Infants

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Bifidobacterium bifidum supplementation

Placebo contains dextrin

About this trial

This is an interventional treatment trial for Preterm Infants focused on measuring probiotics, preterm infants, enteral feeding, Bifidobacterium on enteral feeding

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Infants with birth weight less than 1500g

Exclusion Criteria:

Sever bacteremia
Congenital anomaly
Not suitable for the trial defined by an attending neonatologist

Sites / Locations

Tokyo Women's Medical Unversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Bifidobacterium bifidum

Dextrin without Bifidobacterium bifidum

Outcomes

Primary Outcome Measures

Postnatal day when enteral feeding exceeded at 100ml/kg/day

Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.

Secondary Outcome Measures

standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)

BW gain/day, SD scores of BW and HC at discharge from NICU

Necrotizing enterocolitis or sepsis

The incidences of necrtizing enterocolitis or sepsis during the stay in NICU

Intestinal flora

Intestinal flora during the stay in NICU

Full Information

NCT ID

NCT01375309

First Posted

June 6, 2011

Last Updated

March 28, 2012

Sponsor

Tokyo Women's Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01375309

Brief Title

Bifidobacterium Supplementation for Very Low Birth Weight Infants

Acronym

Bifido(RCT)

Official Title

Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tokyo Women's Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infants

Keywords

probiotics, preterm infants, enteral feeding, Bifidobacterium on enteral feeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Active Comparator

Arm Description

Bifidobacterium bifidum

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Dextrin without Bifidobacterium bifidum

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidobacterium bifidum supplementation

Other Intervention Name(s)

Bifidobacterium bifidum OLB6378

Intervention Description

Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo contains dextrin

Intervention Description

0.5 of dextrin

Primary Outcome Measure Information:

Title

Postnatal day when enteral feeding exceeded at 100ml/kg/day

Description

Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.

Time Frame

From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth

Secondary Outcome Measure Information:

Title

standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)

Description

BW gain/day, SD scores of BW and HC at discharge from NICU

Time Frame

For the duration of NICU stay, an expected average of 3 months

Title

Necrotizing enterocolitis or sepsis

Description

The incidences of necrtizing enterocolitis or sepsis during the stay in NICU

Time Frame

For the duration of NICU stay, an expected average of 3 months

Title

Intestinal flora

Description

Intestinal flora during the stay in NICU

Time Frame

For the duration of NICU stay, an expected average of 3 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

48 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infants with birth weight less than 1500g Exclusion Criteria: Sever bacteremia Congenital anomaly Not suitable for the trial defined by an attending neonatologist

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Satoshi Kusuda, MD

Organizational Affiliation

Tokyo Women's Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tokyo Women's Medical Unversity

City

Shinjuku

State/Province

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

33058137

Citation

Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.

Results Reference

derived

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Bifidobacterium Supplementation for Very Low Birth Weight Infants

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