Evaluation of a Novel Human Milk Fortifier in Preterm Infants
This study has been completed.
Sponsor:
Abbott Nutrition
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
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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 |
Resource links provided by NLM:
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
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 | |
| 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
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 May 23, 2013