Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

NCT01443091 | Completed

• 1 other identifier: CMNPSU-35083
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Low Birth Weight Infants

Keywords

very low birth weight infants; VLBW infants; colostrum

Outcome Measures

Primary Outcomes (1)

• Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age

  2 weeks of age

Secondary Outcomes (2)

• time to reach full enteric feeds

  first few weeks of age

• episodes of suspected or culture positive sepsis

  initial hospital stay 1-3 months

Study Arms (2)

Colostrum

EXPERIMENTAL

Other: application of mother's own colostrum

Sterile water

PLACEBO COMPARATOR

Other: application of sterile water

Interventions

application of mother's own colostrum 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)

Colostrum

application of sterile water 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)

Sterile water

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Children's Miracle Network: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

• Kristen M Glass, MD

  Penn State Milton S. Hershey Medical Center/Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 29, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 30, 2017

Record last verified: 2015-04

Locations

US (1)