Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Summary

Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.

Conditions

• Very Low Birth Weight Infants

Interventions

OTHER

application of mother's own colostrum

application of 0.2mL of mother's own colostrum to the infant's oropharyngeal mucosa every 3 hours for 5 days (day of life 2 until day of life 7)

OTHER

application of sterile water

application of 0.2mL sterile water to the infant's oropharyngeal mucosa every 3 hours for 5 days (from day of life 2 until day of life 7)

Sponsors & Collaborators

• Children's Miracle Network

  collaborator OTHER

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Kristen M Glass, MD · Penn State Milton S. Hershey Medical Center/Penn State College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

3 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2013-06-30

Completion

2013-12-31

Countries

• United States

Study Locations