Analysis, Event HistoryNCT01423942
Maturation of the Autonomic Nervous System in Prematures
An observational study of Analysis, Event History, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures. Read more about this study
- Who is it for?
- Ages 1 day to 100 daysHealthy volunteers can take part
- Conditions the study is for
- Analysis, Event History
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Dec 2014
- 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 100 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Prematures
Who may be able to join
- All prematures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.
Read the detailed description
To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.
- Conditions
- Analysis, Event History
What is being measured
The primary outcome is the main question the study is designed to answer.
Herat rate variability (HRV) characteristics
It is well known that maturation of the autonomic nervous system can be detected by heart rate variability in children. The purpose of this study is to apply HRV characteristics in premature infants and try to evaluate if there are noticable changes in these parameters both in "healthy" and diseased premature infants longitudinally during their stay at the NICU. Outcome measures to be studied are very low frequency ( VLF), low-frequency ( LF), high frequency (HF) frequency bands in the power spectrum density (PSD) of HRV records.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analysis, Event HistoryStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wamir, Rambam Health Care Campus
- Investigators
- Amir Weissman, MD, Principal investigator, RMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423942
- Sponsor's protocol ID
- RMB-0215-11
- Status last verified
- May 2015
- First submitted
- 23 Aug 2011
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maturation of the Autonomic Nervous System in Prematures
- ClinicalTrials.gov ID
- NCT01423942
- Acronym / sponsor ID
- RMB-0215-11
- Conditions
- Analysis, Event History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Aug 2011 (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 purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.
Detailed description
To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 100 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Prematures
Key inclusion criteria (1 listed)
- All prematures
Key exclusion criteria (0 listed)
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
Herat rate variability (HRV) characteristics
Time frame: 3 years
It is well known that maturation of the autonomic nervous system can be detected by heart rate variability in children. The purpose of this study is to apply HRV characteristics in premature infants and try to evaluate if there are noticable changes in these parameters both in "healthy" and diseased premature infants longitudinally during their stay at the NICU. Outcome measures to be studied are very low frequency ( VLF), low-frequency ( LF), high frequency (HF) frequency bands in the power spectrum density (PSD) of HRV records.
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 8 May 2015.
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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.
Amir Weissman, MD principal investigator
RMC
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 Analysis, Event History, run by Rambam Health Care Campus at 1 site in Israel.
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 0 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 8 May 2015. 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 Israel. 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?
Herat rate variability (HRV) characteristics (time frame: 3 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 8 May 2015.