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Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

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 May 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01117324
First Posted: May 5, 2010
Last Update Posted: May 5, 2010
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
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.

Condition
Bone Density

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Bone density [ Time Frame: 1 week ]

Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Primary Completion Date: July 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 infants of birth weight 4 kg and above and infants of diabetic mothers
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Preterms,
  • Major congenital malformations,
  • Sick babies.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Ayala Maayan-Metzger, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01117324     History of Changes
Other Study ID Numbers: SHEBA-10-7637-AM-CTIL
First Submitted: May 4, 2010
First Posted: May 5, 2010
Last Update Posted: May 5, 2010
Last Verified: May 2010

Keywords provided by Sheba Medical Center:
Bone density
infant of diabetic mother
large birth weight

Additional relevant MeSH terms:
Fetal Diseases
Pregnancy in Diabetics
Pregnancy Complications