Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
- Conditions
- Complication of Prematurity
- Interventions
- Dietary Supplement: Powder HMFDietary Supplement: Liquid HMF
- Registration Number
- NCT02632266
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk
- Newborn infants <28 weeks and >34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Powder HMF Powder HMF Once patient has reached 80ml/kg/day of enteral feedings, 1 pack of powder HMF will be added to 50 ml of human or donor breast milk, then increased to a maximum of 2 packs for 50 ml following the unit feeding advancement protocol and this will be continued up until 48 hours prior to discharge. Liquid HMF Liquid HMF Once patient has reached 80ml/kg/day of enteral feedings, researchers will add 1 packet (5 ml) of liquid HMF to 50 ml of human or donor breast milk, then increase to 2 packs to 50 ml following the unit feeding protocol and this will be continued up until 48 hours prior to discharge.
- Primary Outcome Measures
Name Time Method Cumulative weight gain Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier Weight gain of baby during the course of the study
Change in weight Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier Weight gain of baby week-to-week, during the course of the study
Linear length Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier change in length week-to-week during the course of the study
Head growth Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier Change in head measurements week-to-week during the course of the study
- Secondary Outcome Measures
Name Time Method Nutrition biomarkers Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier Measurements of a baby's Ca, P, Mg, Alkaline Phosphatase and Prealbumin will be taken
Tolerance to enteral feeds Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier number of significant residuals, number of times feeds were held, NEC
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States