study pre-term formula
Other24 kcal/fl oz pre-term formula for in-hospital use
Other names: Similac Special Care
NCT Number: NCT01766011
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.
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All sexes
Interventional
Phase 2 / Phase 3
University of South Alabama - Children's and Women's Hospital, Mobile, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
24 kcal/fl oz pre-term formula for in-hospital use
Other names: Similac Special Care
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
weight gain per day (g/kg/d)
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Growth, change in length
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured.
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Blood biochemistries
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Growth, change in head circumference
Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
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
Gastro-Intestinal Tolerance
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Blood biochemistries
Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Blood biochemistries
Abbott Nutrition
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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