Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss, Women's Studies |
Therapuetic Areas: | Endocrinology, Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 3/16/2015 |
Start Date: | January 2011 |
Contact: | Kristen M Glass, M.D. |
Email: | kglass1@hmc.psu.edu |
Phone: | 717-531-8413 |
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.
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.
Inclusion Criteria:
- infants with a birth weight less than 1500 grams (or 3.3 lbs) born at Penn State
Hershey Medical Center and admitted to the PSUCH NICU immediately after birth
Exclusion Criteria:
- Infants with major congenital anomalies or chromosomal syndromes incompatible with
life Infants of mothers not willing to provide colostrum for their infant in the
first week of life Infants of mothers with known HIV, Hepatitis B or Hepatitis C as
these infections may be transmitted through breast milk
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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