Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Very Low Birth Weight Infants |
Other: application of mother's own colostrum Other: application of sterile water |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants |
- Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
- time to reach full enteric feeds [ Time Frame: first few weeks of age ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]number of documented septic events either culture proven or those treated with a full course of antibiotics 7-14 days
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Colostrum |
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)
|
| Placebo Comparator: Sterile water |
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)
|
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Kristen M Glass, M.D. | 717-531-8413 | kglass1@hmc.psu.edu |
| Contact: Barbara Shocker | 717-531-3754 | bshocker@hmc.psu.edu |
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Kristen M Glass, MD 717-531-8413 kglass1@hmc.psu.edu | |
| Principal Investigator: Kristen M Glass, MD | |
| Principal Investigator: | Kristen M Glass, MD | Penn State Milton S. Hershey Medical Center/Penn State College of Medicine |
More Information
No publications provided
| Responsible Party: | Kristen M. Glass, Assistant Professor of Pediatrics, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01443091 History of Changes |
| Other Study ID Numbers: | CMNPSU-35083 |
| Study First Received: | September 26, 2011 |
| Last Updated: | September 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Milton S. Hershey Medical Center:
|
very low birth weight infants VLBW infants colostrum |
Additional relevant MeSH terms:
|
Birth Weight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013