NCT01536093

Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 48 Hours – 96 Hours
• Healthy volunteers: Accepted

Summary

Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.

Conditions

• Extremely Low Gestational Age Newborn
• Premature Infant

Interventions

Type	Name	Description
OTHER	oropharyngeal administration of own mother's colostrum	application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
OTHER	oropharyngeal administration of sterile water	application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-02-20
• Last updated: 2014-08-13
• Results posted: 2014-08-12

Locations

1 site across 1 country: South Korea