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| Sponsored by: |
Mead Johnson |
|---|---|
| Information provided by: | Mead Johnson |
| ClinicalTrials.gov Identifier: | NCT00681018 |
Purpose
To evaluate weight gain of preterm infants fed fortified human milk.
| Condition | Intervention |
|---|---|
|
Premature Infants |
Other: Liquid human milk fortifier Other: Powder human milk fortifier |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
| Official Title: | Feeding Study in Premature Infants |
| Estimated Enrollment: | 143 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Liquid human milk fortifier
|
Other: Liquid human milk fortifier
Liquid human milk fortifier added to human milk
|
|
2: Active Comparator
Powder human milk fortifier
|
Other: Powder human milk fortifier
Powder human milk fortifier added to human milk
|
Eligibility| Ages Eligible for Study: | up to 40 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| The University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Florida | |
| Plantation General Hospital | |
| Plantation, Florida, United States, 33317 | |
| University of Florida | |
| Jacksonville, Florida, United States, 32209 | |
| University of Florida | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Illinois | |
| Advocate Lutheran General Children's Hospital | |
| Park Ridge, Illinois, United States, 60068 | |
| Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| United States, Nebraska | |
| Children's Hospital | |
| Omaha, Nebraska, United States, 68114 | |
| United States, North Carolina | |
| Pitt County Memorial Hospital | |
| Greenville, North Carolina, United States, 27834 | |
| Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| SEAHEC | |
| Wilmington, North Carolina, United States, 28402 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Virginia | |
| Fairfax Hospital | |
| Falls Church, Virginia, United States, 22046 | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| Study Director: | Carol Lynn Berseth, MD | Mead Johnson |
More Information
| Responsible Party: | Mead Johnson ( Carol Lynn Berseth, M.D. ) |
| Study ID Numbers: | 3379-1 |
| Study First Received: | May 15, 2008 |
| Last Updated: | December 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00681018 |
| Health Authority: | United States: Institutional Review Board |
|
premature infants |
