Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
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.
Inclusion Criteria:

 1. Birth weight 750-1800 grams

 2. Admitted to AU NICU within 24 hours of life

 3. Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score

 4. Birth weight appropriate for gestational age (AGA) defined as >3rd% on a
 gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)

 5. Enteral feedings initiated within 7 days of life

 6. Breastmilk diet, maternal or donor milk

 Exclusion Criteria:

 1. Renal conditions affecting electrolyte metabolism and/or excretion

 2. Gastro-intestinal conditions that preclude feeding or affect nutrient absorption
 (gastroschisis, omphalocele)

 3. EGA >33 weeks or birth weight >1800 grams or EGA <23 weeks or birth weight <750 grams

 4. Apgar <3 at 5 minutes

 5. Grade 3 or higher intraventricular hemorrhage (IVH)

 6. Intrauterine growth restriction (IUGR), as defined as <3rd% on a gender-specific
 Fenton growth curve

 7. Congenital anomalies including congenital heart disease or other major defect
 requiring surgical intervention

 8. Intake of cow's milk formula or fortifier before or after the initiation of the study
 protocol