NCT02306980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

December 1, 2014

Last Update Submit

July 21, 2017

Conditions

Changes in the Oral Microbiota

Outcome Measures

Primary Outcomes (1)

  • Oral microbiota

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

    Difference between enrollment, 48 hours and 96 hours

Study Arms (2)

Colostrum

EXPERIMENTAL

Colostrum administration

Other: Colostrum

Control

NO INTERVENTION

Routine care

Interventions

ColostrumOTHER

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

Colostrum

Eligibility Criteria

Age12 Hours - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • lethal condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Children's Hospital

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

    PMID: 26658119DERIVED

Study Officials

  • Mark A Underwood, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Study Completion

June 1, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

US(1)