Preterm Infants Fed a Human Milk Fortifier

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Abbott Nutrition
Study ID
NCT05551975
Status
Not Yet Recruiting

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Conditions

  • Growth

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Control Product — OTHER
    Fed from Study Day 1
  • Experimental Product 1 — OTHER
    Fed from Study Day 1
  • Experimental Product 2 — OTHER
    Fed from Study Day 1

Study Details

This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).

Key Dates

Start date
Sep 30, 2024
Status verified
Jun 2024
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
321 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Control Product
    Control Human Milk Fortifier added to human milk feedings
  • Experimental: Product 1
    Study Human Milk Fortifier added to human milk feedings
  • Experimental: Product 2
    Study Human Milk Fortifier added to human milk feedings

Primary Outcome Measure

Weight [ Time Frame: Study Day 1 to Study Day 29 or Hospital Discharge if first ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Banner - University Medical CenterPhoenixArizona85006-
UAMS Medical CenterLittle RockArkansas72205-
Connecticut Children's Medical CenterHartfordConnecticut06106-
South Miami HospitalMiamiFlorida33143-
AdventHealthOrlandoFlorida32803-
University of South FloridaTampaFlorida33606-
Tufts Medical CenterBostonMassachusetts02111-
Children's Mercy HospitalKansas CityMissouri64108-
University of New Mexico Children's HospitalAlbuquerqueNew Mexico87106-
North Shore University HospitalManhassetNew York11030-
Duke University Medical CenterDurhamNorth Carolina27710-
The Woman's Hospital of TexasHoustonTexas77054-
St. Luke's Baptist HospitalSan AntonioTexas78229-
WVU Medicine Children's HospitalMorgantownWest Virginia26505-

Find similar trials in Phoenix, AZ

By research site
Banner - University Medical Center· Phoenix, AZUAMS Medical Center· Little Rock, ARConnecticut Children's Medical Center· Hartford, CTSouth Miami Hospital· Miami, FLAdventHealth· Orlando, FLUniversity of South Florida· Tampa, FL

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