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

Completed · Not applicable

Conditions studied: Prematurity

In brief

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.

Key facts

Study ID

NCT01776268

Run by

Vanderbilt University Medical Center

People needed

99

Starts

2013-02-01

Expected to finish

2016-09-01

Last updated by the study team

2017-07-07

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

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…

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

Where it is running

• Monroe Carell Jr Children's Hospital at Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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