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NCT01117324 Clinical Trial

Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

Bone Density Clinical Trial

Official title:
Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01117324
Other study ID # SHEBA-10-7637-AM-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 4, 2010
Last updated May 4, 2010
Start date June 2010

Study information
Verified date May 2010
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Days
Eligibility Inclusion Criteria:

- Term infants of birth weight 4 kg and above, and

- Infants of diabetic mothers.

Exclusion Criteria:

- Preterms,

- Major congenital malformations,

- Sick babies.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Bone density 1 week No
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