Evaluation of Human Milk Fortifiers in Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.

Official Title
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Evaluation of Two Human Milk Fortifiers in Preterm Infants

Conditions
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Infant Growth

Intervention / Treatment
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* Other: Human Milk Fortifier A
* Other: Human Milk Fortifier B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight of 700 g-1500 g. ≤ 32 weeks and 0 days GA at birth. Appropriate for GA (AGA). Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0). Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified. Parent(s) agrees to allow infant to receive both human milk and HMF. Singleton or twin births only. Exclusion Criteria: Enteral feeding of preterm infant formula or HMF for > 7 days. Expected to be transferred to another facility and will not be able to be followed for at least 15 days. Serious congenital abnormalities or underlying disease that may affect growth and development. 5 minute APGAR ≤ 4. Steroids used at the time of randomization. Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH). Mechanical ventilator dependence. Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy. Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia). Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24). Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment). Infant has any other condition that, in the opinion of the investigator, precludes participation in the study. Participation in another study that has not been approved as a concomitant study by AN.
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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Human Milk Fortifier A<br>Acidified processing method. | Other: Human Milk Fortifier A<br>* Acidified concentrated liquid human milk fortifier<br>|
| Experimental: Study Human Milk Fortifier B<br>Non-acidified processing method. | Other: Human Milk Fortifier B<br>* Non-acidified concentrated liquid human milk fortifier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain | scale measurement g/kg/d | Study Day 1 to Study Day 29 (or discharge, whichever happens first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance | healthcare professional completed questionnaire | Study Day 1 to Study Day 29 (or discharge, whichever happens first) | 
| Length | measured cm/wk | Study Day 1 to Study Day 29 (or discharge, whichever happens first) | 
| Head Circumference | measured cm/wk | Study Day 1 to Study Day 29 (or discharge, whichever happens first) |