Overview

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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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)
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)

Primary Outcomes

Measure
Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age
time frame: 2 weeks of age

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

Official title Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
Principal investigator Kristen M Glass, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.