Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants

NCT01776268 | Completed Results DMC

• 1 other identifier: 121760
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors. An immature immune system underlies the frequency and severity of infections in this vulnerable population. The mouth is the site where microbes first meet the mucosal immune system. Antimicrobial proteins and peptides (APPs) in saliva kill microbes and improve immune cell function. Low APP levels increase the risk of developing infection. Colostrum and human milk reduce the risk of infection. This protective effect of human milk may come from supplying or stimulating infant production of APPs. No prior investigation has determined the concentration of APPs in saliva or the effect of human milk/formula on the APP concentrations in saliva. Objective(s) and Hypothesis(es): The investigators objectives are to identify and serially determine the concentrations of key APPs in colostrum, human milk, and preterm infant saliva using highly-sensitive and specific mass spectroscopy methods. The investigators study is designed to test the hypotheses that (a) all saliva APPs increase over time, (b) APP concentrations are higher in colostrum as compared to human milk, and (c) APPs are increased in saliva of infants that receive colostrum orally compared to those that do not. Potential Impact: If increased saliva APP levels are associated with oral colostrum priming, this discovery would advance understanding of the immune properties of human milk and identify oral APPs as important immune elements and potential therapeutic targets in this vulnerable population. This knowledge has the potential to alter feeding practices and provide a safe, low cost means to improve immune function and significantly improve outcomes for preterm infants.

Conditions

Prematurity

Keywords

antimicrobial proteins

Outcome Measures

Primary Outcomes (2)

• Concentration of APPs Before Oral Priming

  Saliva will be sampled on day 1-2 of life prior to oral priming. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.

  days 1-2 of life

• Concentration of APPs After Oral Priming

  Saliva will be sampled 24-48 hours after the 5-days of oral priming is completed. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.

  days 7-9 of life

Study Arms (2)

Oral priming

EXPERIMENTAL

Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.

Other: Oral priming

No oral priming

NO INTERVENTION

No oral priming

Interventions

Oral priming OTHER

Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.

Oral priming

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Very low birth weight (\<1500 g)
• Gestational age \<30 weeks
• Admission to NICU (born at Vanderbilt or transferred in for care)
• English or Spanish-speaking parents

You may not qualify if:

• Parent does not give study consent
• Has congenital anomalies, chromosomal disorder or medical contraindication to oral/enteral feedings

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Monroe Carell Jr Children's Hospital at Vanderbilt University

Nashville, Tennessee, 37232-0656, United States

Location

Related Publications (1)

• Romano-Keeler J, Azcarate-Peril MA, Weitkamp JH, Slaughter JC, McDonald WH, Meng S, Latuga MS, Wynn JL. Oral colostrum priming shortens hospitalization without changing the immunomicrobial milieu. J Perinatol. 2017 Jan;37(1):36-41. doi: 10.1038/jp.2016.161. Epub 2016 Sep 29.

  PMID: 27684425 BACKGROUND

Related Links

• Oral colostrum priming shortens hospitalization without changing the immunomicrobial milieu

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: James Wynn MD
• Organization: Vanderbilt University Medical Center

james.wynn@peds.ufl.edu

Study Officials

• James L Wynn, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 28, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2016
• Last Updated: July 7, 2017
• Results First Posted: July 7, 2017

Record last verified: 2017-06

Locations

US (1)