Bone Density of Newborn Infants to Mothers Treated With Selective Serotonin Reuptake Inhibitor (SSRI)

January 7, 2009 updated by: Sheba Medical Center
SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant women with depression or anxiety is extendent and raising. The effect of bone density of the infants was not yet evaluated.

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 newborn infants to mothers treated with SSRI and healthy controls. bone density mesurment will be applied on the 1-7 days of life.

Description

Inclusion Criteria:

  • Term newborn infants to mothers treated with SSRI and healthy controls

Exclusion Criteria:

  • Preterms, major congenital malformations.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone density
Time Frame: 1 month
1 month
bone density
Time Frame: 2 years
2 years

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

February 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

January 8, 2009

Last Update Submitted That Met QC Criteria

January 7, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-09-5435-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.

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