Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Fortification | Active Comparator | receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study |
|
| Adjustable fortification | Experimental | encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human milk fortifier | Dietary Supplement | Then 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach 100kcal/kg/d of enteral nutrition | Days to reach 100kcal/kg/d of enteral nutrition | participants will be followed until discharge, an expected average of 2 weeks |
| The weight gain velocity during hospitalization | The weight gain velocity(g/kg/d) | participants will be followed until discharge, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The protein and energy ratio of enteral nutrition each week after enrollment | The protein and energy ratio(g/100kcal) | participants will be followed until discharge, an expected average of 2 weeks |
| Time to reach 2000g of body weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Danhua Wang, Professor | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 9, 2017 | |
| Reset | Aug 24, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 9, 2017 | Aug 24, 2018 |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Days to reach 2000g of body weight
| participants will be followed until discharge, an expected average of 2 weeks |
| metabolic indicators after enrollment, including BUN,prealbumin, albumin | BUN(mmol/L), prealbumin(mg/L), albumin(g/L) | participants will be followed until discharge, an expected average of 2 weeks |