Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Very Low Birth Weight Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Colostrum

Group Type EXPERIMENTAL

application of mother's own colostrum

Intervention Type OTHER

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)

Sterile water

Group Type PLACEBO_COMPARATOR

application of sterile water

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type 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)

Intervention Type OTHER

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

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes