Autonomic Nervous SystemNCT01769118
The Influences of Caffeine on Heart Rate Variability of Preterm Infants
An observational study of Autonomic Nervous System, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods. Read more about this study
- Who is it for?
- Ages 25 to 34 weeks
- Conditions the study is for
- Autonomic Nervous System
- What is being tested?
- Caffeine
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 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 25 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 25 preterm infants
Who may be able to join
- infants born before 34 weeks gestation
Who cannot join
- sepsis
- congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influences of Caffeine on HRV of Preterm Infants
Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.
- Conditions
- Autonomic Nervous System
- Being tested
- Caffeine
- Keywords
- Autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Caffeine will be given according to departmental protocol
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | caffeine will be given according to clinical judgment Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Heart rate, SD, SDNN, HF, LF, VLF, TP
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous SystemStudies 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
- Time perspective
- Prospective
- Enrolment
- 25 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769118
- Sponsor's protocol ID
- 0442-12
- Status last verified
- May 2015
- First submitted
- 14 Jan 2013
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- The Influences of Caffeine on HRV of Preterm Infants
- ClinicalTrials.gov ID
- NCT01769118
- Acronym / sponsor ID
- 0442-12
- Conditions
- Autonomic Nervous System
- Keywords
- Autonomic nervous system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Jan 2013 (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.
Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caffeine | – | Drug: Caffeinecaffeine will be given according to clinical judgment |
Who may qualify
- Ages
- 25 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 25 preterm infants
Key inclusion criteria (1 listed)
- infants born before 34 weeks gestation
Key exclusion criteria (2 listed)
- sepsis
- congenital malformations
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 |
|---|---|---|
| CaffeineCaffeine will be given according to departmental protocol | Drug | Caffeine |
Primary outcome
Heart rate variability
Time frame: 1 hour
Heart rate, SD, SDNN, HF, LF, VLF, TP
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Autonomic Nervous System, 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 2 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?
Heart rate variability (time frame: 1 hour). 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.