The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier grow according to established guidelines and maintain adequate micronutrient levels.
To achieve this goal, the investigators will prospectively analyze the growth and micronutrient status of VLBW infants who are fed human milk (maternal or donor) supplemented with a human-milk-based fortifier with increased protein (Medolac® Human Milk Fortifier). In addition, the investigators will compare the findings to retrospectively collected data for growth rates and micronutrient status of infants who received human milk fortified with cow's milk -based fortifier (Enfamil® Hydrolyzed Liquid Human Milk Fortifier). The investigators hypothesize that a human milk-based fortifier with increased protein will support growth at recommended levels (weight gain of 12-18 g/kg/day, head circumference 0.75-1.0 cm/week, length 0.8-1.1 cm/week)\[1-3\] and prevent micronutrient deficiency in the VLBW infant Aim 1: To determine if VLBW infants fed human milk, maternal or donor, supplemented with a human milk-based fortifier with increased protein grow at recommended levels for weight, length, and head circumference. To achieve this aim, Z-scores for weight, length, and head circumference will be tracked. Measurements will be taken at birth and then weekly until 36 weeks post-menstrual age (PMA) or discharge from the neonatal intensive care unit (NICU), whichever comes first. Aim 2: To measure nutritional status in VLBW premature infants fed human milk supplemented with a human milk-based fortifier with increased protein. To achieve this aim, serum magnesium, potassium, chloride, blood urea nitrogen (BUN), creatinine, sodium, calcium, phosphorus, CO2, Vitamin D 1, 25 (OH) 2D, parathyroid hormone (PTH), alkaline phosphatase, hemoglobin, hematocrit will be measured within 24 hours of reaching full enteral feedings and repeated seven days later, and then every fourteen days until 36 weeks PMA or discharge, whichever comes first. Urine magnesium and sodium will be measured on the same schedule. Aim 3: To compare growth rates and nutritional status of VLBW infants fed human milk fortified with a human milk-based fortifier to growth rates and nutritional status of those fed human milk fortified with a cow's milk-based fortifier.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
A human milk fortifier with added minerals made from donor human milk
Augusta University
Augusta, Georgia, United States
Return to birth weight day
Day of life infant returns to birth weight
Time frame: birth to 30 days
Growth Velocity
rate of weight gain measured as g/kg/day
Time frame: Weekly until 36 weeks post menstrual age or discharge
Mean Serum Magnesium
Serum and urine Magnesium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean Serum CO2
Serum CO2
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean z-scores
z-scores for weight, length, and head circumference
Time frame: Weekly until 36 weeks post menstrual age or discharge
Mean serum Vitamin D, 1 25 (OH) 2D
serum Vitamin D
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum parathyroid Hormone (PTH)
Serum PTH
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Sodium
Serum and urine Sodium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Blood Urea Nitrogen (BUN)
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serum BUN
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Calcium
serum Calcium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Phosphorus
serum Phosphorus
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Alkaline Phosphatase
serum Alkaline Phosphatase
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Hemoglobin
serum Hemoglobin
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Potassium
serum and urine Potassium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Hematocrit
serum Hematocrit
Time frame: Every 14 days until 36 weeks post menstrual age or discharge