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OpenTrials
Completed

NCT Number: NCT02632266

Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

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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Key information

Age range

28 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Powder HMF

Dietary Supplement

powder human milk fortifier

Liquid HMF

Dietary Supplement

Liquid human milk fortifier

Primary outcomes

  1. Cumulative weight gain

    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

  2. Change in weight

    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

  3. Linear length

    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

  4. Head growth

    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

Secondary outcomes

  1. Nutrition biomarkers

    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

  2. Tolerance to enteral feeds

    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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2015
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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