Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
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ClinicalTrials.gov Identifier: NCT01443091 |
Recruitment Status :
Completed
First Posted : September 29, 2011
Last Update Posted : May 30, 2017
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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 |
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 |

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) |
- Change in salivary secretory Ig-A concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ]
- 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
- 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

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Ages Eligible for Study: | up to 3 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Kristen M Glass, MD | Penn State Milton S. Hershey Medical Center/Penn State College of Medicine |
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 |
very low birth weight infants VLBW infants colostrum |
Body Weight Birth Weight |