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Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota

Primary Purpose

Changes in the Oral Microbiota

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colostrum
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Changes in the Oral Microbiota

Eligibility Criteria

12 Hours - 7 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • premature infant with birth weight < 1500
  • intubated in the first 48 hours of life
  • available maternal colostrum

Exclusion Criteria:

  • lethal condition

Sites / Locations

  • UC Davis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Colostrum

Control

Arm Description

Colostrum administration

Routine care

Outcomes

Primary Outcome Measures

Oral microbiota
Changes in the composition of the community of microbes inhabiting the oral-cavity after administration of oropharyngeal maternal colostrum.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2014
Last Updated
July 21, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02306980
Brief Title
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
Official Title
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. We propose to study the impact of this intervention on the composition of the oral microbiota.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colostrum
Arm Type
Experimental
Arm Description
Colostrum administration
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Other
Intervention Name(s)
Colostrum
Intervention Description
Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.
Primary Outcome Measure Information:
Title
Oral microbiota
Description
Changes in the composition of the community of microbes inhabiting the oral-cavity after administration of oropharyngeal maternal colostrum.
Time Frame
Difference between enrollment, 48 hours and 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: premature infant with birth weight < 1500 intubated in the first 48 hours of life available maternal colostrum Exclusion Criteria: lethal condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Underwood, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Children's Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26658119
Citation
Sohn K, Kalanetra KM, Mills DA, Underwood MA. Buccal administration of human colostrum: impact on the oral microbiota of premature infants. J Perinatol. 2016 Feb;36(2):106-11. doi: 10.1038/jp.2015.157. Epub 2015 Dec 10.
Results Reference
derived

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Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota

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