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

Not Applicable

Completed

• Conditions: Changes in the Oral Microbiota
• Interventions: Other: Colostrum

• Registration Number: NCT02306980
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Primary Completion: 2015-04
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• lethal condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colostrum	Colostrum	Colostrum administration

Primary Outcome Measures

Name	Time	Method
Oral microbiota	Difference between enrollment, 48 hours and 96 hours	Changes in the composition of the community of microbes inhabiting the oral-cavity after administration of oropharyngeal maternal colostrum.

Trial Locations

Locations (1)

UC Davis Children's Hospital; 🇺🇸 Sacramento, California, United States