Status:
UNKNOWN
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Neolac Inc dba Medolac Laboratories
Conditions:
Premature Infant
Breast Milk Expression
Eligibility:
All Genders
23-33 years
Phase:
NA
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 ...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03839173
Start Date
July 25 2019
End Date
March 31 2020
Last Update
July 29 2019
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912