Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

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.

Study Overview

• Status: Completed
• Conditions: Very Low Birth Weight Infants
• Intervention / Treatment: Other: application of mother's own colostrum; Other: application of sterile water

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Children's Miracle Network
• Investigators: Principal Investigator: Kristen M Glass, MD, Penn State Milton S. Hershey Medical Center/Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: colostrum; very low birth weight infants; VLBW infants
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: CMNPSU-35083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No