Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

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

Detailed Description
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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.

Official Title
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Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Conditions
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Infant, Premature, Diseases

Intervention / Treatment
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* Dietary Supplement: human milk fortifier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Days
Maximum Age: 40 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Fortification<br>receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study | Dietary Supplement: human milk fortifier<br>* 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<br>* Other names: HMF;|
| Experimental: Adjustable fortification<br>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) | Dietary Supplement: human milk fortifier<br>* 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<br>* Other names: HMF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |