Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

NCT ID: NCT02622373

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Premature Birth Preterm Birth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PEA POD Infant Body Composition System

Intervention Type 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.

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.

PEA POD Infant Body Composition System

Intervention Type 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.

Birth at Term

Body composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge.

PEA POD Infant Body Composition System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vishal Pandey, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Vishal Pandey, M.D.

Assistant Professor, Department of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vishal Pandey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24808483 (View on PubMed)

Other Identifiers

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STUDY00002323

Identifier Type: -

Identifier Source: org_study_id

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