NCT00005105

Brief Summary

OBJECTIVES: I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

January 1, 1997

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

April 6, 2000

Last Update Submit

June 23, 2005

Conditions

Intrauterine Growth Retardation

Keywords

endocrine disordersintrauterine growth retardationrare disease

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Intrauterine growth retardation (IUGR), defined as birth weight less than 2 standard deviations below the mean by Usher and McLean Deficient "catch-up" growth (stature less than 5th percentile on growth chart after age 18 months) Normal or elevated circulating concentrations of insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) IGF-I or IGFBP-3 within or above the 95th percentile confidence interval for age No other clinical explanation for poor prenatal and postnatal growth No IUGR due to maternal toxemia, endocrine disease, gastrointestinal disease, significant heart disease, or chromosomal abnormalities No other condition known to retard growth

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

TERMINATED

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

ACTIVE NOT RECRUITING

Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

RECRUITING

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

RECRUITING

Medical College of Virginia School of Medicine

Richmond, Virginia, 23298-0230, United States

RECRUITING

MeSH Terms

Conditions

Fetal Growth RetardationEndocrine System DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Steven D. Chernausek

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 6, 2000

First Posted

April 7, 2000

Study Start

January 1, 1997

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(5)