Osteopenia Of PrematurityNCT00631397
A Preliminary Study of Bone Density in Neonates
An observational study of Osteopenia Of Prematurity, run by University of South Florida at 1 site in United States.
Trial summary
The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time. Read more about this study
- Who is it for?
- Ages 24 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Osteopenia Of Prematurity
- What is being tested?
- Ultrasound machine
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 2008
- 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 24 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature Infants In the Neonatal Intensive Care Unit
Who may be able to join
- premature infants born less than 33 weeks, weighing less than 1500 gms
Who cannot join
- congenital anomalies weight greater than 1500 gms
Trial locations and contacts
1 site in 1 country.
United States1 site
Tampa General Hospital/University of South Florida
Tampa, Florida, 33606
About this study
Official title: A Preliminary Study of Bone Density Measurements in Neonates Using the Sunlight Omnisense 7000P Ultrasound Bone Sonometer
The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.
Read the detailed description
premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible for the study
- Conditions
- Osteopenia Of Prematurity
- Being tested
- Ultrasound machine
- Keywords
- weakening of the bones
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound machineDevice
Also called Omnisense 7000P Ultrasound Bone Sonometer
Weekly Bone Density measurements using the Sonometer
| Study group | Role | What they receive |
|---|---|---|
| Premature Infants | Premature Infants weighing less than 1500 gms Receives: Device: Ultrasound machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop ways to prevent and treat Osteopenia of Prematurity
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia Of PrematurityStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terri L Ashmeade, M.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631397
- Sponsor's protocol ID
- 5974
- Other IDs
- University of South Florida, Grant
- Status last verified
- Mar 2007
- First submitted
- 27 Feb 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Bone Density Measurements in Neonates Using the Sunlight Omnisense 7000P Ultrasound Bone Sonometer
- ClinicalTrials.gov ID
- NCT00631397
- Acronym / sponsor ID
- 5974
- Conditions
- Osteopenia Of Prematurity
- Keywords
- weakening of the bones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Mar 2008 (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.
The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.
Detailed description
premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible for the study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature Infants | – | Device: Ultrasound machinePremature Infants weighing less than 1500 gms |
Who may qualify
- Ages
- 24 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature Infants In the Neonatal Intensive Care Unit
Key inclusion criteria (1 listed)
- premature infants born less than 33 weeks, weighing less than 1500 gms
Key exclusion criteria (1 listed)
- congenital anomalies weight greater than 1500 gms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound machineAlso: Omnisense 7000P Ultrasound Bone SonometerWeekly Bone Density measurements using the Sonometer | Device | Premature Infants |
Primary outcome
Develop ways to prevent and treat Osteopenia of Prematurity
Time frame: 1-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
Related trials for Osteopenia Of Prematurity
RecruitingObservational study
Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity
Exosomes, Newborn
Not yet recruiting
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Vitamin D Deficiency, Osteopenia of Prematurity
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.
Terri L Ashmeade, M.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopenia Of Prematurity, run by University of South Florida at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Develop ways to prevent and treat Osteopenia of Prematurity (time frame: 1-2 years). 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 15 Jun 2012.