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This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Product | Active Comparator | Control Human Milk Fortifier added to human milk feedings |
|
| Product 1 | Experimental | Study Human Milk Fortifier added to human milk feedings |
|
| Product 2 | Experimental | Study Human Milk Fortifier added to human milk feedings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Product | Other | Fed from Study Day 1 |
| |
| Experimental Product 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight gain per day | Study Day 1 to Study Day 29 or Hospital Discharge if first |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Length gains per week | Study Day 1 to Study Day 15 and Study Day 29 |
| Length | Attained length in cm | Study Day 1, 8, 15, 22, 29 and Hospital Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Chemistries | Electrolytes, minerals, BUN, alkaline phosphatase | Study Day 1 to Study Day 29 |
| Medications | Medication usage including frequency and reason for use |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen S DeLuca, MS, RDN, LDN | Contact | 614-645-5455 | kristen.deluca@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Reverri, PhD, MS, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner - University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| UAMS Medical Center |
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| Other |
Fed from Study Day 1 |
|
| Experimental Product 2 | Other | Fed from Study Day 1 |
|
| Head Circumference | Head circumference gains per week | Study Day 1 to Study Day 15 and Study Day 29 |
| Head Circumference (HC) | Attained HC in cm | Study Day 1, 8, 15, 22, 29 and Hospital Discharge |
| Weight | Attained weight in grams | Study Day 1, 8, 15, 22, 29 and Hospital Discharge |
| Weight | Weight gain per day | Study Day 1 to Study Day 15 |
| Stool Characteristics | Percent bloody, black, watery, or hard stools | Study Day 1 to Study Day 29 |
| Feeding Intolerance | Percent periods NPO, feedings withheld due to gastrointestinal intolerance | Study Day 1 to Study Day 29 |
| Full Enteral Feeds | Days to achieve full enteral feeds | Study Day 1 to Study Day 29 |
| Study Day 1 to Study Day 29 |
| Length of Stay | Number of days in hospital | From birth until Discharge, typically 60 days |
| Stool Sample | Characterization of microbiota, immunity | Study Day 1 to Study Day 29 |
| Blood Sample for Immunity/Inflammation | Cytokines | Study Day 1 to Study Day 29 |
| Adverse Events | Number of participants with adverse events (AEs) and concurrent expected events | Study Day 1 until Discharge, typically 60 days |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| South Miami Hospital | Miami | Florida | 33143 | United States |
| AdventHealth | Orlando | Florida | 32803 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of New Mexico Children's Hospital | Albuquerque | New Mexico | 87106 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Woman's Hospital of Texas | Houston | Texas | 77054 | United States |
| St. Luke's Baptist Hospital | San Antonio | Texas | 78229 | United States |
| WVU Medicine Children's Hospital | Morgantown | West Virginia | 26505 | United States |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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