NCT01117324

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

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

May 5, 2010

Status Verified

May 1, 2010

Enrollment Period

1.1 years

First QC Date

May 4, 2010

Last Update Submit

May 4, 2010

Conditions

Keywords

Bone densityinfant of diabetic motherlarge birth weight

Outcome Measures

Primary Outcomes (1)

  • Bone density

    1 week

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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