Clinical Trials Directory

Trials / Completed

CompletedNCT01731613

Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
10 Days – 40 Days
Healthy volunteers
Not accepted

Summary

This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENThuman milk fortifierThen fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen

Timeline

Start date
2012-08-01
Primary completion
2017-08-01
Completion
2017-08-01
First posted
2012-11-22
Last updated
2017-11-28

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01731613. Inclusion in this directory is not an endorsement.