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Evaluation of a Novel Human Milk Fortifier in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01373073
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : February 20, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Preterm Infants Other: Experimental human milk fortifier Other: Control human milk fortifier Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Study Start Date : August 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Weight gain [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Anthropometric variables [ Time Frame: 29 days ]
    Length and head circumference

  2. GI tolerance [ Time Frame: 29 days ]
    stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
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

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): 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
University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01373073     History of Changes
Other Study ID Numbers: AK37
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

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