Feeding Study in VLBW Premature Infants

Study Overview
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Brief Summary
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A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk

Official Title
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Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)

Conditions
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VLBW - Very Low Birth Weight Infant

Intervention / Treatment
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* Other: Exempt Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically and metabolically stable Birth weight 700 g to less than or equal to 1,250 g Appropriate birth weight for gestational age 24 0/7 to 32 0/7 weeks' gestational age at birth Exclusively fed human milk Signed informed consent and authorization to use and/or disclose PHI Exclusion Criteria: Metabolic or chronic disease 5-minute Apgar score <4 Major surgery Ventilator dependent Fluid restriction Grade III or IV intraventricular hemorrhage (IVH)

Ages Eligible for Study
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Minimum Age: 168 Days
Maximum Age: 224 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Commercial Liquid Human Milk Fortifier<br>Liquid human milk fortifier to be added to human milk | Other: Exempt Infant Formula<br>* Liquid human milk fortifier to be added to human milk daily<br>|
| Experimental: Liquid Human Milk Fortifier - Standard Protein<br>Liquid human milk fortifier to be added to human milk | Other: Exempt Infant Formula<br>* Liquid human milk fortifier to be added to human milk daily<br>|
| Experimental: Liquid Human Milk Fortifier - High Protein<br>Liquid human milk fortifier to be added to human milk | Other: Exempt Infant Formula<br>* Liquid human milk fortifier to be added to human milk daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain | grams/kg/day | Daily for 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding Tolerance | Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume) | Daily for 28 days | 
| Rate of Length and head circumference gain | cm/week | weekly up to day 28 | 
| Total energy intake | kcal | 28 days | 
| Total protein intake | grams | 28 days | 
| Respiratory status | Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation | 28 days | 
| Incidence of NEC | Modified Bell's Staging Criteria | Study Day 0 through 28 | 
| Incidence of sepsis - clinical symptoms | Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate | Study Day 0 through 28 | 
| Incidence of sepsis - culture for pathogens | Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant | Study day 0 through 28 | 
| Incidence of sepsis - Antibiotic use | Antibiotic use duration - less than 5 days ; 5 days or more | Study Day 0 through 28 | 
| Total serum CO2 | less than 18 mmol/L | Study days 0, 14, 28 | 
| Metabolic Acidosis | If CO2 <18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L) | Study days 0, 14, 28 |