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N/A N=99 Randomized Diagnostic

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

Prematurity

Enrolled (actual)
99
Serious AEs
1.0%
Results posted
Jul 2017
Primary outcome: Primary: Concentration of APPs Before Oral Priming — 17; 22; 35; 42 femtomole (fmol)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Oral priming (Other)
Age
Pediatric
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Mar 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Concentration of APPs Before Oral Priming
17; 22; 35; 42; 101; 102
PRIMARY
Concentration of APPs After Oral Priming
15; 20; 18; 38; 144; 206

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Does not meet inclusion criteria
  • Parent does not give study consent
  • Has congenital anomalies, chromosomal disorder or medical contraindication to oral/enteral feedings
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01776268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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