Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

July 18, 2016 updated by: Vishal Pandey, M.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Birth Between 23-32 Weeks Gestation
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.
Device: PEA 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.
Birth Between 34-36 Weeks Gestation
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.
Device: PEA 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.
Birth at Term
Body composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge.
Device: PEA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
40 weeks corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vishal Pandey, M.D.

Investigators

  • Principal Investigator: Vishal Pandey, MD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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