CClinicalTrials.gg
CompletedNCT00681018Updated Aug 31, 2010

Feeding Study in Premature Infants

An interventional study of Liquid human milk fortifier and Powder human milk fortifier in Premature Infants, sponsored by Mead Johnson Nutrition. Completed at 14 sites in United States. Open to participants aged Up to 40 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-31.

Sponsored by Mead Johnson Nutrition · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
Up to 40 Days
Sex
All
01

Study summary

To evaluate weight gain of preterm infants fed fortified human milk.

02

Conditions studied

  • Premature Infants

Browse trials for

Keywords

  • premature
  • infants
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 143 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Mead Johnson Nutrition is the lead sponsor of 56 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 40 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • premature infant
  • birth weight less than/equal to 1250 g
  • exclusively breast fed

Exclusion criteria

Exclusion Criteria:

  • metabolic or chronic disease
  • major surgery
  • ventilator dependent
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
143 participants (estimated)

Study arms

  • Experimental
    1

    Liquid human milk fortifier

    Other: Liquid human milk fortifier

  • Active comparator
    2

    Powder human milk fortifier

    Other: Powder human milk fortifier

Interventions

  • OtherLiquid human milk fortifier

    Liquid human milk fortifier added to human milk

    Also known as: No other names -- experimental product

  • OtherPowder human milk fortifier

    Powder human milk fortifier added to human milk

    Also known as: Enfamil Human Milk Fortifier

06

What researchers measure

Primary outcomes

  1. Weight gain

    Time frame: 28 days

Secondary outcomes

  1. Feeding tolerance

    Time frame: 28 days

07

Study locations

14 sites
  • The University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • University of Florida
    Jacksonville, Florida 32207, United States
  • University of Florida
    Jacksonville, Florida 32209, United States
  • Plantation General Hospital
    Plantation, Florida 33317, United States
  • All Children's Hospital
    St. Petersburg, Florida 33701, United States
  • Advocate Hope Children's Hospital
    Oak Lawn, Illinois 60453, United States
  • Advocate Lutheran General Children's Hospital
    Park Ridge, Illinois 60068, United States
  • Children's Hospital
    Omaha, Nebraska 68114, United States
  • Queen's Hospital
    Jamaica, New York 11432, United States
  • Pitt County Memorial Hospital
    Greenville, North Carolina 27834, United States
  • SEAHEC
    Wilmington, North Carolina 28402, United States
  • Forsyth Medical Center
    Winston-Salem, North Carolina 27103, United States
  • Fairfax Hospital
    Falls Church, Virginia 22046, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00681018
Lead sponsor
Mead Johnson Nutrition
First posted
May 20, 2008
Start date
Sep 2008
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Aug 31, 2010

Study contacts

Carol Lynn Berseth, MD
study director · Mead Johnson Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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