A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
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| ClinicalTrials.gov Identifier: NCT03512613 |
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Recruitment Status : Unknown
Verified May 2018 by Ornim Medical.
Recruitment status was: Recruiting
First Posted : May 1, 2018
Last Update Posted : June 4, 2018
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Congenital Heart Defect Cerebrovascular Circulation | Device: c-FLOW 3310-P |
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 Type : | Observational |
| Estimated Enrollment : | 55 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects |
| Estimated Study Start Date : | May 29, 2018 |
| Estimated Primary Completion Date : | May 2019 |
| Estimated Study Completion Date : | May 2019 |
- Device: c-FLOW 3310-P
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.
- 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)
- The correlation between Auto-regulation index and Neurological outcomes [ Time Frame: 3 hours monitoring per day, for 4 days ]
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.
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| Ages Eligible for Study: | up to 4 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512613
| Contact: Omer Bar Yosef, MD | +97252-6667344 | Omer.BarYosef@sheba.health.gov.il | |
| Contact: Oliana Vazhgovsky, BA | oliana.vazhgovsky@sheba.health.gov.il |
| Israel | |
| Sheba Medical Center | Recruiting |
| Ramat Gan, Israel | |
| Contact: Omer Bar Yosef, MD +972-526667344 Omer.BarYosef@sheba.health.gov.il | |
| Contact: Oliana Vazhgovsky, SC +972-542641448 oliana.vazhgovsky@sheba.health.gov.il | |
| Principal Investigator: | Omer Bar Yosef, MD | Sheba Medical Center |
| Responsible Party: | Ornim Medical |
| ClinicalTrials.gov Identifier: | NCT03512613 |
| Other Study ID Numbers: |
RDCL- IL-SMC-021 |
| First Posted: | May 1, 2018 Key Record Dates |
| Last Update Posted: | June 4, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |