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OpenTrials
Completed

NCT Number: NCT02622373

Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

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.

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Key information

Age range

23 week–42 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

Babies born premature weigh significantly less at the time of hospital discharge when compared to babies born at the corresponding age. The researchers in this study believe that the lower body weight at discharge may be due to lower muscle mass. However, there is no such information available for that at this time. It is important to have this information as babies who weigh less than normal at hospital discharge may develop higher blood pressure and higher sugar levels when they are 10-15 years old.

By doing this study, researchers will be able to have information about the baby's muscle mass, which will help the researchers to provide better nutrition to babies who are born premature. Researchers will also be able to determine if there are any differences in the muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a combination of breast milk and formula). This information may be beneficial in helping to promote the appropriate type of feeding for babies born premature.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns <32 weeks gestational age, singleton or multiple gestation
  • 34-36 weeks gestational age newborns
  • Term healthy infants from uncomplicated pregnancy

Exclusion criteria

  • Babies with life threatening illness unlikely to survive
  • Congenital and chromosomal anomalies

Treatment and study plan

PEA POD Infant Body Composition System

Device

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.

Primary outcomes

  1. Change in the Fat mass percentage between 36 and 40 weeks in preterm infants

    Time frame: Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age

    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.

Secondary outcomes

  1. Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.

    Time frame: 40 weeks corrected age

    The Fat mass percentage in preterm infants at the 40 weeks corrected age would be compared with healthy full term infants born following an uncomplicated pregnancy.

Sponsors and collaborators

Lead sponsor

Vishal Pandey, M.D.

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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