Clinical Trial: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
Brief Summary: This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
Detailed Summary: A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.
Sponsor: Peking Union Medical College Hospital
Current Primary Outcome: Assessment of nutrient concentration of human milk [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Biochemical assessment of blood sample [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ]
- Body Weight [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ]
- Body length and Head circumference [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ]
Original Secondary Outcome: Same as current
Information By: Peking Union Medical College Hospital
Dates:
Date Received: November 5, 2012
Date Started: August 2012
Date Completion: April 2017
Last Updated: March 31, 2016
Last Verified: March 2016
