Breast Milk Expression, Premature Infant
Conditions
Keywords
premature infant, breast milk, breastmilk, human milk, human milk fortifier
Brief summary
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.
Detailed description
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.
Interventions
OTHERHuman milk based human milk fortifier
A human milk fortifier with added minerals made from donor human milk
Sponsors
Neolac Inc dba Medolac Laboratories
Augusta University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 33 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to birth weight day | birth to 30 days | Day of life infant returns to birth weight |
| Growth Velocity | Weekly until 36 weeks post menstrual age or discharge | rate of weight gain measured as g/kg/day |
| Mean Serum Magnesium | Every 14 days until 36 weeks post menstrual age or discharge | Serum and urine Magnesium |
| Mean Serum CO2 | Every 14 days until 36 weeks post menstrual age or discharge | Serum CO2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean serum Blood Urea Nitrogen (BUN) | Every 14 days until 36 weeks post menstrual age or discharge | serum BUN |
| Mean serum Calcium | Every 14 days until 36 weeks post menstrual age or discharge | serum Calcium |
| Mean serum Phosphorus | Every 14 days until 36 weeks post menstrual age or discharge | serum Phosphorus |
| Mean z-scores | Weekly until 36 weeks post menstrual age or discharge | z-scores for weight, length, and head circumference |
| Mean serum Hemoglobin | Every 14 days until 36 weeks post menstrual age or discharge | serum Hemoglobin |
| Mean serum Potassium | Every 14 days until 36 weeks post menstrual age or discharge | serum and urine Potassium |
| Mean serum Hematocrit | Every 14 days until 36 weeks post menstrual age or discharge | serum Hematocrit |
| Mean serum Alkaline Phosphatase | Every 14 days until 36 weeks post menstrual age or discharge | serum Alkaline Phosphatase |
| Mean serum Vitamin D, 1 25 (OH) 2D | Every 14 days until 36 weeks post menstrual age or discharge | serum Vitamin D |
| Mean serum parathyroid Hormone (PTH) | Every 14 days until 36 weeks post menstrual age or discharge | Serum PTH |
| Mean serum Sodium | Every 14 days until 36 weeks post menstrual age or discharge | Serum and urine Sodium |
Countries
United States
Outcome results
None listed