Congenital Heart DefectNCT03512613
A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
An observational study of Congenital Heart Defect and Cerebrovascular Circulation, run by Ornim Medical at 1 site in Israel.
Trial summary
Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Congenital Heart Defect, Cerebrovascular Circulation
- What is being tested?
- c-FLOW 3310-P
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- 29 May 2018to May 2019
- 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 4 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with congenital heart disease scheduled for repair surgery
Who may be able to join
- Mutual parents' consent (outstanding exceptional cases who approved by the EC)
- Born at gestational age of more than 34+6/7 weeks
- Cardiac surgery between 0- 4 weeks of age
- Head circumference >= 31 cm
Who cannot join
- Patient with implants located in the intended area of the c-FLOW 3310-P sensor location.
- Laceration of scalp injury at the intended area of the c-FLOW 3310-P sensors
- Known brain malformation
- Hydrocephalus
- Resuscitation between the time of surgery and neurological outcome assessment
Trial locations and contacts
1 site in 1 country.
Oliana Vazhgovsky, BA contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Omer Bar Yosef, MD, +972-526667344, Omer.BarYosef@sheba.health.gov.il
Oliana Vazhgovsky, SC, +972-542641448, oliana.vazhgovsky@sheba.health.gov.il
About this study
Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury.
There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery.
Read more
The previous modal of the study device has been cleared for marketing by the FDA (k150268).
The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.
Read the detailed description
55 eligible neonates whom have been deemed as candidates for a cardiac surgery will be enroll to the study.
At the first phase, 10 neonates will be monitored. After the investigator has assessed the patient as eligible for the study and consent will be received by the parents, the subject will be provided with a study enrollment number.
All clinical assessments routinely preformed as per standard of care during all hospitalization, such as hemodynamic continues parameters, discreet samples will be documented in the medical records, and later on the requested assessments will be recorded in the designated Case Report Form.
Monitoring will be performed a day prior to the repair surgery, following the surgery at the same day and one and two days after, for 3 hours per day.
Additional standard of care parameters will be collected :Heart rate, Mean Arterial Blood Pressure, Saturation, Ventilator rate, Medications, Blood gases ( blood tests), Echocardiogram, pre-surgery Head US,. additional examination will be performed intended for the study: two post surgery Head US, S100B biomarker for brain injury and Neurological examinations prior and 7 days post- surgery( By standardized questionnaires).
Sample size: 55:
A sample size of 55 will enable to detect an increase of 20% in flow with a standard deviation of 50 assuming normal distribution a type 1 error of 5% and power of 80%.
In order to evaluate the study design and data quality the sponsor will perform an interim analysis for the 10 first neonates.
Quality assurance: Following the study initiation monitoring visit will be performed for the first patient. Additional visits will be performed according to recruitment rate. Source data verification and safety events follow up will be performed during those visits.
Plan for missing data: Every effort will be made to complete follow-up for all subjects and avoid missing data, in particular regarding essential items.
Statistical analysis: Descriptive statistics will be used to summarize results. Categorical measurements will be presented in contingency tables with counts \& percent.
Continuous measurements will be presented with N, means ±Standard Deviation, or median with 25th \& 75th percentiles Minimum \& Maximum.
The percent of change in flow pre \& post maneuver will be calculated using one sample t-test.
Spearman correlation will be used to correlate the autoregulation index and neurological outcomes.
Significance level will be defined as a=0.05. Statistical analyses will be carried out using SPSS (Statistical Package for the Social Sciences) 24.01 software.
- Being tested
- c-FLOW 3310-P
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-FLOW 3310-PDevice
c-FLOW 3310-P is a continuous, non-invasive monitor of cerebral deep tissue blood flow used to measure relative changes in blood flow.
The device monitors regional micro circulatory blood flow in tissues, by using sensors placed near the area of interest.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in c-Flow3310-P following routine maneuvers
Changes will be measured following routine maneuvers such as suction, leg lifting, Blood sample, changing position, feeding, presence of feeding tube etc.
Change= (CFI(manipulation)- CFI(baseline))- CFI(baseline)
Measured: 3 hours monitoring per day, for 4 days
Secondary outcomes (1)
The correlation between Auto-regulation index and Neurological outcomes
Auto regulation index (the correlation of Cerebral Flow Index\& Mean Arterial Pressure)
Neurological outcomes based on two validated questionnaires:
PCPC (Pediatric Cerebral Performance Category) scale- ranging from 1-6 PSOM ( Pediatric Stroke Outcome Measure) scale - ranging from 1 to 10.
Measured: 3 hours monitoring per day, for 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start29 May 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ornim Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omer Bar Yosef, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512613
- Sponsor's protocol ID
- RDCL- IL-SMC-021
- Status last verified
- May 2018
- First submitted
- 22 Feb 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govindan RB, Massaro AN, Andescavage NN, Chang T, du Plessis A. Cerebral pressure passivity in newborns with encephalopathy undergoing therapeutic hypothermia. Front Hum Neurosci. 2014 Apr 24;8:266. doi: 10.3389/fnhum.2014.00266. eCollection 2014.
PubMed 24795612Massaro AN, Govindan RB, Vezina G, Chang T, Andescavage NN, Wang Y, Al-Shargabi T, Metzler M, Harris K, du Plessis AJ. Impaired cerebral autoregulation and brain injury in newborns with hypoxic-ischemic encephalopathy treated with hypothermia. J Neurophysiol. 2015 Aug;114(2):818-24. doi: 10.1152/jn.00353.2015. Epub 2015 Jun 10.
PubMed 26063779Tsalach A, Ratner E, Lokshin S, Silman Z, Breskin I, Budin N, Kamar M. Cerebral Autoregulation Real-Time Monitoring. PLoS One. 2016 Aug 29;11(8):e0161907. doi: 10.1371/journal.pone.0161907. eCollection 2016.
PubMed 27571474Hori D, Hogue CW Jr, Shah A, Brown C, Neufeld KJ, Conte JV, Price J, Sciortino C, Max L, Laflam A, Adachi H, Cameron DE, Mandal K. Cerebral Autoregulation Monitoring with Ultrasound-Tagged Near-Infrared Spectroscopy in Cardiac Surgery Patients. Anesth Analg. 2015 Nov;121(5):1187-93. doi: 10.1213/ANE.0000000000000930.
PubMed 26334746Rachelia, N. (2012). Non-Invasive Blood Flow Measurements Using Ultrasound Modulated Diffused Light. In Photons Plus Ultrasound: Imaging and Sensing 2012.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT03512613
- Acronym / sponsor ID
- RDCL- IL-SMC-021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ornim MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 1 May 2018 (actual)
- 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.
Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury.
There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery.
The previous modal of the study device has been cleared for marketing by the FDA (k150268).
The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.
Detailed description
55 eligible neonates whom have been deemed as candidates for a cardiac surgery will be enroll to the study.
At the first phase, 10 neonates will be monitored. After the investigator has assessed the patient as eligible for the study and consent will be received by the parents, the subject will be provided with a study enrollment number.
All clinical assessments routinely preformed as per standard of care during all hospitalization, such as hemodynamic continues parameters, discreet samples will be documented in the medical records, and later on the requested assessments will be recorded in the designated Case Report Form.
Monitoring will be performed a day prior to the repair surgery, following the surgery at the same day and one and two days after, for 3 hours per day.
Additional standard of care parameters will be collected :Heart rate, Mean Arterial Blood Pressure, Saturation, Ventilator rate, Medications, Blood gases ( blood tests), Echocardiogram, pre-surgery Head US,. additional examination will be performed intended for the study: two post surgery Head US, S100B biomarker for brain injury and Neurological examinations prior and 7 days post- surgery( By standardized questionnaires).
Sample size: 55:
A sample size of 55 will enable to detect an increase of 20% in flow with a standard deviation of 50 assuming normal distribution a type 1 error of 5% and power of 80%.
In order to evaluate the study design and data quality the sponsor will perform an interim analysis for the 10 first neonates.
Quality assurance: Following the study initiation monitoring visit will be performed for the first patient. Additional visits will be performed according to recruitment rate. Source data verification and safety events follow up will be performed during those visits.
Plan for missing data: Every effort will be made to complete follow-up for all subjects and avoid missing data, in particular regarding essential items.
Statistical analysis: Descriptive statistics will be used to summarize results. Categorical measurements will be presented in contingency tables with counts \& percent.
Continuous measurements will be presented with N, means ±Standard Deviation, or median with 25th \& 75th percentiles Minimum \& Maximum.
The percent of change in flow pre \& post maneuver will be calculated using one sample t-test.
Spearman correlation will be used to correlate the autoregulation index and neurological outcomes.
Significance level will be defined as a=0.05. Statistical analyses will be carried out using SPSS (Statistical Package for the Social Sciences) 24.01 software.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with congenital heart disease scheduled for repair surgery
Key inclusion criteria (4 listed)
- Mutual parents' consent (outstanding exceptional cases who approved by the EC)
- Born at gestational age of more than 34+6/7 weeks
- Cardiac surgery between 0- 4 weeks of age
- Head circumference >= 31 cm
Key exclusion criteria (5 listed)
- Patient with implants located in the intended area of the c-FLOW 3310-P sensor location.
- Laceration of scalp injury at the intended area of the c-FLOW 3310-P sensors
- Known brain malformation
- Hydrocephalus
- Resuscitation between the time of surgery and neurological outcome assessment
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 |
|---|---|---|
| c-FLOW 3310-Pc-FLOW 3310-P is a continuous, non-invasive monitor of cerebral deep tissue blood flow used to measure relative changes in blood flow. The device monitors regional micro circulatory blood flow in tissues, by using sensors placed near the area of interest. | Device | – |
Primary outcome
Change in c-Flow3310-P following routine maneuvers
Time frame: 3 hours monitoring per day, for 4 days
Changes will be measured following routine maneuvers such as suction, leg lifting, Blood sample, changing position, feeding, presence of feeding tube etc. Change= (CFI(manipulation)- CFI(baseline))- CFI(baseline)
1 secondary outcome
The correlation between Auto-regulation index and Neurological outcomes
Time frame: 3 hours monitoring per day, for 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Results publication: PubMed 24795612Govindan RB, Massaro AN, Andescavage NN, Chang T, du Plessis A. Cerebral pressure passivity in newborns with encephalopathy undergoing therapeutic hypothermia. Front Hum Neurosci. 2014 Apr 24;8:266. doi: 10.3389/fnhum.2014.00266. eCollection 2014.
- Results publication: PubMed 26063779Massaro AN, Govindan RB, Vezina G, Chang T, Andescavage NN, Wang Y, Al-Shargabi T, Metzler M, Harris K, du Plessis AJ. Impaired cerebral autoregulation and brain injury in newborns with hypoxic-ischemic encephalopathy treated with hypothermia. J Neurophysiol. 2015 Aug;114(2):818-24. doi: 10.1152/jn.00353.2015. Epub 2015 Jun 10.
- Results publication: PubMed 27571474Tsalach A, Ratner E, Lokshin S, Silman Z, Breskin I, Budin N, Kamar M. Cerebral Autoregulation Real-Time Monitoring. PLoS One. 2016 Aug 29;11(8):e0161907. doi: 10.1371/journal.pone.0161907. eCollection 2016.
- Results publication: PubMed 26334746Hori D, Hogue CW Jr, Shah A, Brown C, Neufeld KJ, Conte JV, Price J, Sciortino C, Max L, Laflam A, Adachi H, Cameron DE, Mandal K. Cerebral Autoregulation Monitoring with Ultrasound-Tagged Near-Infrared Spectroscopy in Cardiac Surgery Patients. Anesth Analg. 2015 Nov;121(5):1187-93. doi: 10.1213/ANE.0000000000000930.
- Results publicationRachelia, N. (2012). Non-Invasive Blood Flow Measurements Using Ultrasound Modulated Diffused Light. In Photons Plus Ultrasound: Imaging and Sensing 2012.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Defect
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
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.
Oliana Vazhgovsky, BA contact
Omer Bar Yosef, MD principal investigator
Sheba Medical Center
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 Congenital Heart Defect and Cerebrovascular Circulation, run by Ornim Medical 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 4 inclusion and 5 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 4 Jun 2018. 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 Omer Bar Yosef, MD (+97252-6667344, Omer.BarYosef@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in c-Flow3310-P following routine maneuvers (time frame: 3 hours monitoring per day, for 4 days). 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 NCT03512613, which also lists 5 linked publications.
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 4 Jun 2018.