Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infants
• Interventions: Other: application of mother's own colostrum; Other: application of sterile water

• Registration Number: NCT01443091
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-29
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colostrum	application of mother's own colostrum	-
Sterile water	application of sterile water	-

Primary Outcome Measures

Name	Time	Method
Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age	2 weeks of age

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States