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

Sponsor

Augusta University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03839173

Collaborator

Neolac Inc dba Medolac Laboratories (Industry)

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Infant Breast Milk Expression	Other: Human milk based human milk fortifier	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

51 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 25, 2019

Anticipated Primary Completion Date :

Mar 31, 2020

Anticipated Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Retrospective Chart Review Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier
Experimental: Prospective 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.	Other: Human milk based human milk fortifier A human milk fortifier with added minerals made from donor human milk

Arm

Intervention/Treatment

No Intervention: Retrospective Chart Review

Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier

Experimental: Prospective

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.

Other: Human milk based human milk fortifier

A human milk fortifier with added minerals made from donor human milk

Outcome Measures

Primary Outcome Measures

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

Mean z-scores [Weekly until 36 weeks post menstrual age or discharge]
z-scores for weight, length, and head circumference
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
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 Alkaline Phosphatase [Every 14 days until 36 weeks post menstrual age or discharge]
serum Alkaline Phosphatase
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 33 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Birth weight 750-1800 grams
Admitted to AU NICU within 24 hours of life
Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score
Birth weight appropriate for gestational age (AGA) defined as >3rd% on a gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)
Enteral feedings initiated within 7 days of life
Breastmilk diet, maternal or donor milk

Exclusion Criteria:

Renal conditions affecting electrolyte metabolism and/or excretion
Gastro-intestinal conditions that preclude feeding or affect nutrient absorption (gastroschisis, omphalocele)
EGA >33 weeks or birth weight >1800 grams or EGA <23 weeks or birth weight <750 grams
Apgar <3 at 5 minutes
Grade 3 or higher intraventricular hemorrhage (IVH)
Intrauterine growth restriction (IUGR), as defined as <3rd% on a gender-specific Fenton growth curve
Congenital anomalies including congenital heart disease or other major defect requiring surgical intervention
Intake of cow's milk formula or fortifier before or after the initiation of the study protocol