Prematurity Clinical Trial: Human Milk Cream as a Caloric Supplement in Pre-Term Infants [Conditions: Prematurity; Interventions: Human Milk Cream]

This Baylor College trial is in collaboration with Prolacta. It will compare outcomes of premature infants fed human milk from a mother or donor which will be tested and if short, brought up to 20 calories per ounce using human cream as an additive, vs the current practice in some NICUs of using human milk fortified with human milk-based fortifier (Prolacta's product) with no specific analysis of each milk feed. It is based on this premise:

"However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth."

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Prematurity Clinical Trial: Human Milk Cream as a Caloric Supplement in Pre-Term Infants [Conditions: Prematurity; Interventions: Human Milk Cream]: Arms, Groups and Cohorts in this Clinical Trial

Experimental:Human Milk Cream Group
For infants randomized to the human milk cream group, the human milk (either mother's own or donor) being provided to the infant will be tested each time a new container is used to prepare feedings. The test will be for the caloric content of the milk using a commercially available device provided for this purpose. If the caloric level falls below 20 kcal/oz for any test, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. The amount added will be calculated to the nearest mL rounding down for 0.1-0.4mL and up for 0.5-0.9 mL to avoid imprecision due to the measuring device used in the nutrition preparation area.
No Intervention: Control Group
For infants randomized to the Control group, human milk and human milk derived fortifier will be provided according to the institutional standard of care and there will be no use of the milk analysis (mother's own or donor), which is typical for the vast majority of neonatal intensive care units.