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

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ClinicalTrials.gov Identifier: NCT02632266
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Vishal Pandey, M.D., 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.

Condition or disease Intervention/treatment Phase
Complication of Prematurity Dietary Supplement: Powder HMF Dietary Supplement: Liquid HMF Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
Study Start Date : July 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Powder HMF
powder human milk fortifier

Active Comparator: 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.
Dietary Supplement: Liquid HMF
Liquid human milk fortifier




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   28 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632266


Contacts
Contact: Amie Slaughter (913) 588-6350 AGRIMM@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Amie Slaughter    913-588-6350    AGRIMM@kumc.edu   
Sponsors and Collaborators
Vishal Pandey, M.D.
Investigators
Principal Investigator: Vishal Pandey, MD University of Kansas Medical Center

Publications of Results:

Responsible Party: Vishal Pandey, M.D., Associate Professor, Neonatology, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02632266     History of Changes
Other Study ID Numbers: STUDY00002292
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Vishal Pandey, M.D., University of Kansas Medical Center:
prematurity
growth
nutrition
human milk fortifier

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications