Preterm Infants Fed a Human Milk Fortifier

Study Overview
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Brief Summary
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This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth tolerance of preterm infants fed human milk fortifier (HMF).

Official Title
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Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier

Conditions
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Growth

Intervention / Treatment
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* Other: Experimental Product
* Other: Control Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight between 700 g-1500 g. ≤ 32 weeks and 0 days GA at birth. Participant has been classified as appropriate for GA (AGA). Enteral feeding of human milk must be 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 with study fortifier. Parent(s) agrees to allow infant to receive both human milk and study HMF. Singleton or twin births only. Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study. Exclusion Criteria: Enteral feeding of preterm infant formula or HMF for > 7 days. Expected to be transferred to another facility within 30 days of randomization. Serious congenital abnormalities or underlying disease that may affect growth and development. 5-minute APGAR ≤ 4. Receiving steroids at time of randomization. Receiving probiotics at time of randomization. Grade Ill or IV PVH/IVH. Dependent on invasive ventilation at time of randomization. Maternal incapacity. Mother or infant is currently receiving treatment consistent with HIV therapy. Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse. Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant. 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. Confirmed NEC (Bell's Stage II or III). Confirmed current sepsis. 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Product<br>Study Human Milk Fortifier added to human milk feedings | Other: Experimental Product<br>* Fed ad libitum from Study Day 1<br>|
| Active Comparator: Control Product<br>Control Human Milk Fortifier added to human milk feedings | Other: Control Product<br>* Fed ad libitum from Study Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | weight gain per day | Study Day 1 to Study Day 29 or Hospital Discharge if first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length | length gains per week | Study Day 1 to Study Day 15 and Study Day 29 | 
| Length | attained length in cm | Study Day 1, 8, 15, 22, 29 and Hospital Discharge | 
| Head Circumference | head circumference gains per week | Study Day 1 to Study Day 15 and Study Day 29 | 
| Head Circumference (HC) | attained HC in cm | Study Day 1, 8, 15, 22, 29 and Hospital Discharge | 
| Weight | attained weight in grams | Study Day 1, 8, 15, 22, 29 and Hospital Discharge | 
| Weight | weight gain per day | Study Day 1 to Study Day 15 | 
| Stool Characteristics | Percent bloody, black, watery, or hard stools | Study Day 1 to Study Day 29 | 
| Feeding Intolerance | Percent periods nil per os (NPO), feedings withheld due to gastrointestinal intolerance | Study Day 1 to Study Day 29 | 
| Full Enteral Feeds | Days to achieve full enteral feeds | Study Day 1 to Study Day 29 |