We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01443091
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
Kristen M. Glass, 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.

Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infants Other: application of mother's own colostrum Other: application of sterile water Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
Study Start Date : January 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ]

Secondary Outcome Measures :
  1. time to reach full enteric feeds [ Time Frame: first few weeks of age ]
    day of life when full enteral feeds attained, defined as a volume of 140-150mL/kg/day

  2. episodes of suspected or culture positive sepsis [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443091


Locations
Layout table for location information
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Children's Miracle Network
Investigators
Layout table for investigator information
Principal Investigator: Kristen M Glass, MD Penn State Milton S. Hershey Medical Center/Penn State College of Medicine
Layout table for additonal information
Responsible Party: Kristen M. Glass, Assistant Professor of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01443091    
Other Study ID Numbers: CMNPSU-35083
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: April 2015
Keywords provided by Kristen M. Glass, Milton S. Hershey Medical Center:
very low birth weight infants
VLBW infants
colostrum
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Birth Weight