Bone DensityNCT01117324
Bone Density of Large Newborn Infants and Infants of Diabetic Mothers
An observational study of Bone Density, run by Sheba Medical Center.
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… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Bone Density
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Healthy term infants of birth weight 4 kg and above and infants of diabetic mothers
Who may be able to join
- Term infants of birth weight 4 kg and above, and
- Infants of diabetic mothers.
Who cannot join
- Preterms,
- Major congenital malformations,
- Sick babies.
About this study
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.
- Conditions
- Bone Density
- Keywords
- Bone density, infant of diabetic mother, large birth weight
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117324
- Sponsor's protocol ID
- SHEBA-10-7637-AM-CTIL
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Density of Large Newborn Infants and Infants of Diabetic Mothers
- ClinicalTrials.gov ID
- NCT01117324
- Acronym / sponsor ID
- SHEBA-10-7637-AM-CTIL
- Conditions
- Bone Density
- Keywords
- Bone density, infant of diabetic mother, large birth weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (estimated)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy term infants of birth weight 4 kg and above and infants of diabetic mothers
Key inclusion criteria (2 listed)
- Term infants of birth weight 4 kg and above, and
- Infants of diabetic mothers.
Key exclusion criteria (3 listed)
- Preterms,
- Major congenital malformations,
- Sick babies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone density
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Density, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2010.