The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.
This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
40
powder human milk fortifier
Liquid human milk fortifier
University of Kansas Medical Center
Kansas City, Kansas, United States
Cumulative weight gain
Weight gain of baby during the course of the study
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Change in weight
Weight gain of baby week-to-week, during the course of the study
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Linear length
change in length week-to-week during the course of the study
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Head growth
Change in head measurements week-to-week during the course of the study
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Nutrition biomarkers
Measurements of a baby's Ca, P, Mg, Alkaline Phosphatase and Prealbumin will be taken
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Tolerance to enteral feeds
number of significant residuals, number of times feeds were held, NEC
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
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