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Evaluation of a Novel Human Milk Fortifier in Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01373073
First received: June 8, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.


Condition Intervention Phase
Preterm Infants
Other: Experimental human milk fortifier
Other: Control human milk fortifier
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometric variables [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Length and head circumference

  • GI tolerance [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.


Enrollment: 147
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Human Milk Fortifier
Experimental human milk fortifier to be added to human milk
Other: Experimental human milk fortifier
Human milk fortifier to be added to human milk feedings
Active Comparator: Control Human Milk Fortifier
Control human milk fortifier to be added to human milk
Other: Control human milk fortifier
Control human milk fortifier to be added to human milk

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 700-1500g birth weight
  • 33 weeks or less gestational age
  • Appropriate for gestational age
  • Initiate enteral feeds of human milk by 21 days of life
  • Mother provided exclusive human milk feeds
  • Parents allow both human milk and study human milk fortifier
  • Singleton or twin birth

Exclusion Criteria:

  • Feeding preterm infant formula or non-study human milk fortifier
  • Expected at facility less than 15 days
  • Congenital anomalies/disease affecting growth and development
  • 5 minute APGAR of 4 or less
  • Steroid use
  • ECMO
  • Grade III or IV PVH/IVH
  • Mechanical ventilator dependency
  • Maternal incapacity
  • History of major surgery
  • Asphyxia
  • Confirmed NEC or sepsis
  • Use of probiotics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373073

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249-7335
United States, California
UCSD Medical Center
San Diego, California, United States, 92103-8774
United States, Florida
University South Florida
Tampa, Florida, United States, 33606
United States, Indiana
Memorial Hospital of Southbend
Southbend, Indiana, United States, 46601
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, New York
King's County Hospital Center
Brooklyn, New York, United States, 11203
Cohen Children's Medical Center of New York at North Shore
Manhasset, New York, United States, 11030
Cohen Children's Medical Center of NY at North Shore
New Hyde Park, New York, United States, 11040
Childrens Hospital Westchester Medical Center
Valhalla, New York, United States, 10595
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Oregon
OHSU
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Bridget Barrett-Reis, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01373073     History of Changes
Other Study ID Numbers: AK37
Study First Received: June 8, 2011
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 23, 2014