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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02306980

Enrollment

Registered

2014-12-03

Start date

2013-10-31

Completion date

2016-06-30

Last updated

2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Changes in the Oral Microbiota

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.

Interventions

OTHERColostrum

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Hours to 7 Days

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026