The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
28
24 kcal/fl oz pre-term formula for in-hospital use
University of South Alabama - Children's and Women's Hospital
Mobile, Alabama, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Wesley Medical Center
Wichita, Kansas, United States
Maria Children's Hospital Westchester Medical Center
Valhalla, New York, United States
Weight gain per day
weight gain per day (g/kg/d)
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Length
Growth, change in length
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Stool Questionnaire
Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured.
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Serum Calcium
Blood biochemistries
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Head circumference
Growth, change in head circumference
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Feeding Questionnaire
Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured.
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Any periods of nil per os (NPO)
Gastro-Intestinal Tolerance
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Phosphorus
Blood biochemistries
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MetroHealth Medical Center
Cleveland, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Wheaton Franciscan Healthcare-St. Joseph
Milwaukee, Wisconsin, United States
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Alkaline Phosphatase
Blood biochemistries
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)