Skip to content

Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02622373
Enrollment
40
Registered
2015-12-04
Start date
2015-06-30
Completion date
2016-01-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth, Preterm Birth

Keywords

Pea Pod, Body composition

Brief summary

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.

Detailed description

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.

Interventions

DEVICEPEA POD Infant Body Composition System

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.

Sponsors

Vishal Pandey, M.D.
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
23 Weeks to 42 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Fat mass percentage between 36 and 40 weeks in preterm infantsChange in the Fat mass percentage between 36 weeks and 40 weeks corrected ageBody 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

MeasureTime frameDescription
Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.40 weeks corrected ageThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026