Bone Density of Large Newborn Infants and Infants of Diabetic Mothers
1 other identifier
observational
40
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedMay 5, 2010
May 1, 2010
1.1 years
May 4, 2010
May 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone density
1 week
Eligibility Criteria
Healthy term infants of birth weight 4 kg and above and infants of diabetic mothers
You may qualify if:
- Term infants of birth weight 4 kg and above, and
- Infants of diabetic mothers.
You may not qualify if:
- Preterms,
- Major congenital malformations,
- Sick babies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 5, 2010
Study Start
June 1, 2010
Primary Completion
July 1, 2011
Last Updated
May 5, 2010
Record last verified: 2010-05