Patent Ductus ArteriosusNCT02380040
Plethismographic Perfusion Index in Neonates
An observational study of Patent Ductus Arteriosus and Persistent Pulmonary Hypertension of the Newborn, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus, Persistent Pulmonary Hypertension of the Newborn
- What is being tested?
- PPG
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Mar 2017
- 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 Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term and Preterm newborns admitted to the neonatology department
Who may be able to join
- PDA, PPHN and Normal babies who underwent echocardiography
Who cannot join
- Other cardiac diseases
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ruben Bromiker
Jerusalem, 91031
Ruben Bromiker, MD, 972508685154, bromi@smc.org.il
Itamar Nitzan, MD, 972507414998, itamarnitzan@gmail.com
About this study
Official title: Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography
Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.
Read the detailed description
Newborn babies admitted to the NICU and well baby will be connected to a specially designed photoplethismograph (PPG). Right hand (pre ductal), and and one of the legs (postductal) values will be compared, based on the formula Delta amplitude of PPG / baseline absorption (perfusion index (PI)). Normal values will be defined in healthy term and preterm babies, and clinical conditions in which the PI is expected to change (Patent Ductus Artheriosus, Persistent pulmonary hypertension of the newborn)will be compared with these normal values.
- Being tested
- PPG
- Medical subject headings
- Ductus Arteriosus, Patent, Persistent Fetal Circulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPGDevice
A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software
| Study group | Role | What they receive |
|---|---|---|
| Term | Normal Term Newborn Intervention: PPG Receives: Device: PPG | |
| Preterm | Preterm babies admitted to the NICU not suffering from the conditions to be studied Intervention: PPG Receives: Device: PPG | |
| PDA | Patent Ductus Arteriosus Intervention: PPG Receives: Device: PPG | |
| PPHN | Persistent Pulmonary Hypertension Intervention: PPG Receives: Device: PPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion Index
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben Bromiker, MD, Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380040
- Sponsor's protocol ID
- 181/14
- Status last verified
- Aug 2016
- First submitted
- 1 Mar 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nitzan I, Hammerman C, Fink D, Nitzan M, Koppel R, Bromiker R. The effect of patent ductus arteriosus on pre-ductal and post-ductal perfusion index in preterm neonates. Physiol Meas. 2018 Jul 20;39(7):075006. doi: 10.1088/1361-6579/aacf25.
PubMed 29943734
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography
- ClinicalTrials.gov ID
- NCT02380040
- Acronym / sponsor ID
- 181/14
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 5 Mar 2015 (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.
Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.
Detailed description
Newborn babies admitted to the NICU and well baby will be connected to a specially designed photoplethismograph (PPG). Right hand (pre ductal), and and one of the legs (postductal) values will be compared, based on the formula Delta amplitude of PPG / baseline absorption (perfusion index (PI)). Normal values will be defined in healthy term and preterm babies, and clinical conditions in which the PI is expected to change (Patent Ductus Artheriosus, Persistent pulmonary hypertension of the newborn)will be compared with these normal values.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Term | – | Device: PPGNormal Term Newborn Intervention: PPG |
| Preterm | – | Device: PPGPreterm babies admitted to the NICU not suffering from the conditions to be studied Intervention: PPG |
| PDA | – | Device: PPGPatent Ductus Arteriosus Intervention: PPG |
| PPHN | – | Device: PPGPersistent Pulmonary Hypertension Intervention: PPG |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term and Preterm newborns admitted to the neonatology department
Key inclusion criteria (1 listed)
- PDA, PPHN and Normal babies who underwent echocardiography
Key exclusion criteria (1 listed)
- Other cardiac diseases
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 |
|---|---|---|
| PPGA PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software | Device | PDA, PPHN, Preterm, Term |
Primary outcome
Perfusion Index
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 29943734Nitzan I, Hammerman C, Fink D, Nitzan M, Koppel R, Bromiker R. The effect of patent ductus arteriosus on pre-ductal and post-ductal perfusion index in preterm neonates. Physiol Meas. 2018 Jul 20;39(7):075006. doi: 10.1088/1361-6579/aacf25.
- Individual participant dataSharing planned: Undecided
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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.
Ruben Bromiker, MD principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
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 Patent Ductus Arteriosus and Persistent Pulmonary Hypertension of the Newborn, run by Shaare Zedek Medical Center 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 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 7 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben Bromiker, MD (972508685154, bromi@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion Index (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380040, which also lists 1 linked publication.
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 7 Sep 2016.