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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
22
Liquid human milk fortifier to be added to human milk daily
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Augusta University
Augusta, Georgia, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
NYU Langone Hospital, Long Island
Mineola, New York, United States
Weight gain
grams/kg/day
Time frame: Daily for 28 days
Feeding Tolerance
Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)
Time frame: Daily for 28 days
Rate of Length and head circumference gain
cm/week
Time frame: weekly up to day 28
Total energy intake
kcal
Time frame: 28 days
Total protein intake
grams
Time frame: 28 days
Respiratory status
Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation
Time frame: 28 days
Incidence of NEC
Modified Bell's Staging Criteria
Time frame: 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
Time frame: Study Day 0 through 28
Incidence of sepsis - culture for pathogens
Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant
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Cohen Children's Medical Center of NY
New Hyde Park, New York, United States
Weill Cornell Medicine
New York, New York, United States
Time frame: Study day 0 through 28
Incidence of sepsis - Antibiotic use
Antibiotic use duration - less than 5 days ; 5 days or more
Time frame: Study Day 0 through 28
Total serum CO2
less than 18 mmol/L
Time frame: 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)
Time frame: Study days 0, 14, 28