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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818727
First Posted: January 8, 2009
Last Update Posted: January 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
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.

Condition
Bone Density

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • bone density [ Time Frame: 1 month ]
  • bone density [ Time Frame: 2 years ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Preterms, major congenital malformations.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr.Ayala Maayan, sheba medical center
ClinicalTrials.gov Identifier: NCT00818727     History of Changes
Other Study ID Numbers: SHEBA-09-5435-AM-CTIL
First Submitted: January 7, 2009
First Posted: January 8, 2009
Last Update Posted: January 8, 2009
Last Verified: January 2009

Keywords provided by Sheba Medical Center:
Bone density
SSRI
newborn infants

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs