Clinical Trial: Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
Brief 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.
Detailed Summary:
Sponsor: Milton S. Hershey Medical Center
Current Primary Outcome: Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- time to reach full enteric feeds [ Time Frame: first few weeks of age ]day of life when full enteral feeds attained, defined as a volume of 140-150mL/kg/day
- episodes of suspected or culture positive sepsis [ Time Frame: initial hospital stay 1-3 months ]number of documented septic events either culture proven or those treated with a full course of antibiotics 7-14 days
Original Secondary Outcome: Same as current
Information By: Milton S. Hershey Medical Center
Dates:
Date Received: September 26, 2011
Date Started: January 2011
Date Completion:
Last Updated: April 8, 2015
Last Verified: April 2015
