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Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01117324
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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:

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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Bone density [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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

No publications provided

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
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 16, 2013