Human Milk Fortification in Very Low Birth Neonates

Study Overview
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Brief Summary
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The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

Detailed Description
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Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.

Official Title
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Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates

Conditions
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Premature; Infant, Enteral Nutrition, Human Milk, Fortification

Intervention / Treatment
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* Dietary Supplement: Human milk fortifiers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Very low birth weight infants who receive human milk (mother's milk or banked donor human milk). Exclusion Criteria: Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect. Died or extended to die within 48 hours of life

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 7 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fortification at 20 ml/kg/day feeding volume<br>Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day. | Dietary Supplement: Human milk fortifiers<br> <br> |
| Active Comparator: Fortification at 100 ml/kg/day feeding volume<br>human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day. | Dietary Supplement: Human milk fortifiers<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The days to reach full enteral feeding volume (140 ml/kg/day). |  | 4 - 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Outcomes | Necrotizing Enterocolitis | until 36 weeks PMA | 
| Neonatal Outcomes | Chronic Lung Disease | until 36 weeks PMA | 
| Neonatal Outcomes | Feeding intolerance | Until full feeding volume | 
| Neonatal Outcomes | Parental nutrition days | Until full feeding volume | 
| Neonatal Outcomes | Ventilator days | until 36 weeks PMA | 
| Neonatal Outcomes | Protein and caloric intake | until 4 weeks of life | 
| Neonatal Outcomes | Growth anthropometry | until 4 weeks of life |