Infant, Premature, Diseases
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENThuman milk fortifier
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
Sponsors
Mead Johnson Nutrition
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
10 Days to 40 Days
Healthy volunteers
No
Inclusion criteria
* Less than 34 weeks gestational age at birth * Birth weight within 800-1800 grams * Exclusively or mostly breastfed (greater than 80% if the feeding volume) * Tolerated enteral feedings of 60 ml/kg/d * Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment * Signed Informed Consent
Exclusion criteria
* Small for gestational age * Infants currently receiving ventilation therapy * Major congenital malformations * Suspected or documented systemic or congenital infections * Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth * Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia * Suspected or documented maternal substance abuse * Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach 100kcal/kg/d of enteral nutrition | participants will be followed until discharge, an expected average of 2 weeks | Days to reach 100kcal/kg/d of enteral nutrition |
| The weight gain velocity during hospitalization | participants will be followed until discharge, an expected average of 2 weeks | The weight gain velocity(g/kg/d) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The protein and energy ratio of enteral nutrition each week after enrollment | participants will be followed until discharge, an expected average of 2 weeks | The protein and energy ratio(g/100kcal) |
| Time to reach 2000g of body weight | participants will be followed until discharge, an expected average of 2 weeks | Days to reach 2000g of body weight |
| metabolic indicators after enrollment, including BUN,prealbumin, albumin | participants will be followed until discharge, an expected average of 2 weeks | BUN(mmol/L), prealbumin(mg/L), albumin(g/L) |
Countries
China
Outcome results
None listed