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Slow recruitment
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A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial Liquid Human Milk Fortifier | Active Comparator | Liquid human milk fortifier to be added to human milk |
|
| Liquid Human Milk Fortifier - Standard Protein | Experimental | Liquid human milk fortifier to be added to human milk |
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| Liquid Human Milk Fortifier - High Protein | Experimental | Liquid human milk fortifier to be added to human milk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exempt Infant Formula | Other | Liquid human milk fortifier to be added to human milk daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | grams/kg/day | Daily for 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding Tolerance | Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume) | Daily for 28 days |
| Rate of Length and head circumference gain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Augusta University |
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cm/week
| weekly up to day 28 |
| Total energy intake | kcal | 28 days |
| Total protein intake | grams | 28 days |
| Respiratory status | Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation | 28 days |
| Incidence of NEC | Modified Bell's Staging Criteria | Study Day 0 through 28 |
| Incidence of sepsis - clinical symptoms | Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate | Study Day 0 through 28 |
| Incidence of sepsis - culture for pathogens | Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant | Study day 0 through 28 |
| Incidence of sepsis - Antibiotic use | Antibiotic use duration - less than 5 days ; 5 days or more | Study Day 0 through 28 |
| Total serum CO2 | less than 18 mmol/L | Study days 0, 14, 28 |
| Metabolic Acidosis | If CO2 <18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L) | Study days 0, 14, 28 |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Riley Children's Hospital | Indianapolis | Indiana | 46202 | United States |
| NYU Langone Hospital, Long Island | Mineola | New York | 11501 | United States |
| Cohen Children's Medical Center of NY | New Hyde Park | New York | 11040 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |