Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

NCT ID: NCT00833222

Last Updated: 2017-12-26

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

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation \[32-35 weeks post-menstrual age (PMA)\] premature infants.

Detailed Description

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1. To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
2. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
3. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
4. Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Conditions

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Premature Birth

Keywords

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premature birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Full Term Infants

Infants born between 37 4/7 weeks and 42 3/7 weeks gestation.

No interventions assigned to this group

Preterm Infants

Infants born between 32 4/7 weeks and 35 3/7 weeks gestation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth
* Birth weight between the 5th and 95th percentile corrected for gestational age

Exclusion Criteria

* Chromosomal abnormalities
* Major congenital anomalies
* Major surgery
* Severe CNS injury
* Inborn errors of metabolism
* Assisted ventilation
* Inability to start enteral feeds by 96 hours of age
Minimum Eligible Age

31 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurie Moyer-Mileur, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Kristine Jordan, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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24087

Identifier Type: -

Identifier Source: org_study_id