Newborns Delivered at KMC OB/GYN Departmentnewborn O2 satNCT01223573
Neonatal Pulse Oximetry Compared With Apgar Scores
An observational study of Newborns Delivered at KMC OB/GYN Department, run by Kern Medical Center.
Trial summary
Apgar score is a subjective measure to assess prognosis and future outcome of a newborn. Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective times in an goal to assess the usability of pulse oximetry as an added tool in determining the newborn prognosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborns Delivered at KMC OB/GYN Department
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: newborns delivered at KMC OBGYN dept
Who may be able to join
- Newborns delivered vaginaly or by C-section at Kern Medical Center labor and delivery ward
Who cannot join
- known cardiopulmonary disease of the newborn
About this study
Official title: Newborn Pulse Oximety as a Predictor for Newborn Status and Future Outcome As Compared With the Apgar Score
Apgar score is a subjective measure to assess prognosis and future outcome of a newborn. Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective times in an goal to assess the usability of pulse oximetry as an added tool in determining the newborn prognosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborns Delivered at KMC OB/GYN DepartmentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kern Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223573
- Sponsor's protocol ID
- KMC1234
- Other IDs
- KMC1234
- Acronym
- newborn O2 sat
- Status last verified
- Aug 2010
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Pulse Oximety as a Predictor for Newborn Status and Future Outcome As Compared With the Apgar Score
- ClinicalTrials.gov ID
- NCT01223573
- Acronym / sponsor ID
- newborn O2 sat / KMC1234
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kern Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (estimated)
- First posted
- 19 Oct 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.
Apgar score is a subjective measure to assess prognosis and future outcome of a newborn. Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective times in an goal to assess the usability of pulse oximetry as an added tool in determining the newborn prognosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- newborns delivered at KMC OBGYN dept
Key inclusion criteria (1 listed)
- Newborns delivered vaginaly or by C-section at Kern Medical Center labor and delivery ward
Key exclusion criteria (1 listed)
- known cardiopulmonary disease of the newborn
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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 Newborns Delivered at KMC OB/GYN Department, run by Kern 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 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: status not confirmed, as of the sponsor's last update on 19 Oct 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.
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 19 Oct 2010.