Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
Status unconfirmed · Not applicable
Conditions studied: Premature Infant, Breast Milk Expression
In brief
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.
Key facts
- Study ID
- NCT03839173
- Run by
- Augusta University
- People needed
- 51
- Starts
- 2019-07-25
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2019-07-29
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Augusta University — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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