Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Study Overview
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Brief Summary
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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.

Official Title
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Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Conditions
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Very Low Birth Weight Infants

Intervention / Treatment
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* Other: application of mother's own colostrum
* Other: application of sterile water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colostrum<br> | Other: application of mother's own colostrum<br>* 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)<br>|
| Placebo Comparator: Sterile water<br> | Other: application of sterile water<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age |  | 2 weeks of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to reach full enteric feeds | day of life when full enteral feeds attained, defined as a volume of 140-150mL/kg/day | first few weeks of age | 
| episodes of suspected or culture positive sepsis | number of documented septic events either culture proven or those treated with a full course of antibiotics 7-14 days | initial hospital stay 1-3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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very low birth weight infants, VLBW infants, colostrum