NCT00715754

Brief Summary

The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound can predict infant adiposity by air displacement plethysmography at birth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 11, 2010

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

2.4 years

First QC Date

July 10, 2008

Results QC Date

July 21, 2009

Last Update Submit

December 22, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

  • Infant Adiposity at 24-72 Hours Following Birth

    Adiposity as measured by air displacement plethysmography

    24-72 hours following birth

  • Fetal Abdominal Circumference

    Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.

    35 weeks gestation

  • Estimated Fetal Weight Percentile

    Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.

    35 weeks gestation

Eligibility Criteria

Age24 Hours - 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children born at the University of Utah Hospital, whose mothers received prenatal care also at the University of Utah Hospital.

You may qualify if:

  • Infants of mothers between the ages of 18 and 45, planning child birth at the University of Utah Hospital, and willing to provide parental permission for the child to participate in the study.

You may not qualify if:

  • Infants of mothers under the age of 18, over the age of 45, planning child birth at another facility other than the University of Utah Hospital, or who are not willing to provide permission for the child to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Laurie Moyer-Mileur
Organization
University of Utah
Laurie.Moyer-Mileur@hsc.utah.edu
801/587-7488

Study Officials

  • Laurie Moyer-Mileur, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 15, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 23, 2018

Results First Posted

January 11, 2010

Record last verified: 2017-12

Locations

US(1)