Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
This trial is active, not recruiting.
|Condition||very low birth weight infants|
|Treatments||application of mother's own colostrum, application of sterile water|
|Sponsor||Milton S. Hershey Medical Center|
|Collaborator||Children's Miracle Network|
|Start date||January 2011|
|End date||January 2016|
|Trial size||60 participants|
|Trial identifier||NCT01443091, CMNPSU-35083|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age
time frame: 2 weeks of age
time to reach full enteric feeds
time frame: first few weeks of age
episodes of suspected or culture positive sepsis
time frame: initial hospital stay 1-3 months
Male or female participants up to 3 days old.
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
|Official title||Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants|
|Principal investigator||Kristen M Glass, MD|
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