Skip to main content
OpenTrials
Completed

NCT Number: NCT02306980

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Changes in the Oral Microbiota

Age range

12 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Children's Hospital

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • lethal condition

Treatment and study plan

Colostrum

Other

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

Primary outcomes

  1. Oral microbiota

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 3, 2014
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.