Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

May 4, 2010 updated by: Sheba Medical Center
Bone density was found to be impaired among lage babies and infants of diabetic mothers as found in small group studies. The assumption is that large weight decreases fetal movements and causes decreased bone mineralization.The aim of the study is to compare 2 study groups - of large infants and infants of diabetic mothers to each other and to controls.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

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

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy term infants of birth weight 4 kg and above and infants of diabetic mothers

Description

Inclusion Criteria:

  • Term infants of birth weight 4 kg and above, and
  • Infants of diabetic mothers.

Exclusion Criteria:

  • Preterms,
  • Major congenital malformations,
  • Sick babies.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone density
Time Frame: 1 week
1 week

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

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, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-7637-AM-CTIL

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.

Clinical Trials on Bone Density

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe