University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT02632266
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.
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Notify Me28 week–34 week
All sexes
Interventional
Phase 4
Kansas City, Kansas, 66160, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
powder human milk fortifier
Liquid human milk fortifier
Time frame: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
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
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
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
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
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
number of significant residuals, number of times feeds were held, NEC
University of Kansas Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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