NCT02622373|Completed
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Sponsor study identifier
observational
40
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
January 2016
Actual (reported)The purpose of this study is to gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 16, 2015
Actual (reported)December 2015
Actual (reported)December 4, 2015
Actual (reported)January 2016
Actual (reported)Change in the Fat mass percentage between 36 and 40 weeks in preterm infants
Body composition as determined by the PEA POD air displacement plathesmography would determine the fat mass percentage and the serial measure of this parameter would determine the changes in the fat mass percentage indicating the quality of growth between 36 and 40 weeks post conceptional age. At 40 weeks corrected age, the fat mass percentage of the premature infants would be compared with ten healthy term infants born to healthy mothers with uncomplicated pregnancies.
Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age
Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.
40 weeks corrected age
Babies born between 23-32 weeks of gestational age will have their body composition determined using PEA POD Infant Body Composition System at 34 weeks, 36 weeks and 40 weeks of corrected age.
Babies born at 34 weeks and 36 weeks of gestational age will have their body composition measured using PEA POD Infant Body Composition System as soon as they are off parenteral nutrition and receiving full enteral nutrition.
Body composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge.
The non-invasive device used in this study to measure a baby's body composition is a called a Pea Pod. The Pea Pod is a quick, safe, non-invasive and reliable bedside procedure used to measure changes in infant body composition.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study group involves premature infants born between 23 to 32 weeks gestation, while babies born at 34 weeks, 36 weeks and ≥37 and ≤ 42 weeks gestational age will serve as control groups.
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Roze JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.
Vishal Pandey, MD
University of Kansas Medical Center
40 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2015
First Posted
December 4, 2015
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
CellulaR Injury and Preterm Birth
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
July 20, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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