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Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

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

Brief Summary:
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 or disease
Bone Density

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bone Density of Large Newborn Infants and Infants of Diabetic Mothers
Study Start Date : June 2010
Estimated Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density
U.S. FDA Resources

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

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

Inclusion Criteria:

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

Exclusion Criteria:

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

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 Posted: May 5, 2010    Key Record Dates
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