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

Not Applicable

• Conditions: Breast Milk Expression; Premature Infant
• Interventions: Other: Human milk based human milk fortifier

• Registration Number: NCT03839173
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2019-07
• Study Start: 2019-07-25
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective	Human milk based human milk fortifier	All neonates with birth weights ranging from 750-1500 grams and gestational ages 23-33 weeks admitted to the NICU at Augusta University within 24 hours of life will be eligible for screening within 72 hours of admission and upon parent's or legal guardian's consent. Infants will be fed a human milk fortifier made with donor human milk. Data will be compared with historic control data.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean serum parathyroid Hormone (PTH)	Every 14 days until 36 weeks post menstrual age or discharge	Serum PTH
Mean serum Potassium	Every 14 days until 36 weeks post menstrual age or discharge	serum and urine Potassium
Mean serum Alkaline Phosphatase	Every 14 days until 36 weeks post menstrual age or discharge	serum Alkaline Phosphatase
Mean z-scores	Weekly until 36 weeks post menstrual age or discharge	z-scores for weight, length, and head circumference
Mean serum Hematocrit	Every 14 days until 36 weeks post menstrual age or discharge	serum Hematocrit
Mean serum Vitamin D, 1 25 (OH) 2D	Every 14 days until 36 weeks post menstrual age or discharge	serum Vitamin D
Mean serum Sodium	Every 14 days until 36 weeks post menstrual age or discharge	Serum and urine Sodium
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 serum Hemoglobin	Every 14 days until 36 weeks post menstrual age or discharge	serum Hemoglobin

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States