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

NCT ID: NCT02306980

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Changes in the Oral Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Colostrum

Colostrum administration

Group Type EXPERIMENTAL

Colostrum

Intervention Type OTHER

Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.

Control

Routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colostrum

Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* lethal condition
Minimum Eligible Age

12 Hours

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark A Underwood, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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UC Davis Children's Hospital

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26658119 (View on PubMed)

Other Identifiers

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531791

Identifier Type: -

Identifier Source: org_study_id

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