Trial record 5 of 122 for:    Open Studies | "Birth Weight"

Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Milton S. Hershey Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
Kristen M. Glass, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01443091
First received: September 26, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention
Very Low Birth Weight Infants
Other: application of mother's own colostrum
Other: application of sterile water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to reach full enteric feeds [ Time Frame: first few weeks of age ] [ Designated as safety issue: No ]
    day of life when full enteral feeds attained, defined as a volume of 140-150mL/kg/day

  • episodes of suspected or culture positive sepsis [ Time Frame: initial hospital stay 1-3 months ] [ Designated as safety issue: No ]
    number of documented septic events either culture proven or those treated with a full course of antibiotics 7-14 days


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443091

Contacts
Contact: Kristen M Glass, M.D. 717-531-8413 kglass1@hmc.psu.edu
Contact: Barbara Shocker 717-531-3754 bshocker@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Kristen M Glass, MD    717-531-8413    kglass1@hmc.psu.edu   
Principal Investigator: Kristen M Glass, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Children's Miracle Network
Investigators
Principal Investigator: Kristen M Glass, MD Penn State Milton S. Hershey Medical Center/Penn State College of Medicine
  More Information

No publications provided

Responsible Party: Kristen M. Glass, Assistant Professor of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01443091     History of Changes
Other Study ID Numbers: CMNPSU-35083
Study First Received: September 26, 2011
Last Updated: September 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
very low birth weight infants
VLBW infants
colostrum

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014