Congenital Heart Defect Clinical Trial
Official title:
A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
NCT number | NCT03512613 |
Other study ID # | RDCL- IL-SMC-021 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 29, 2018 |
Est. completion date | May 2019 |
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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Weeks |
Eligibility |
Inclusion Criteria: 1. Mutual parents' consent (outstanding exceptional cases who approved by the EC) 2. Born at gestational age of more than 34+6/7 weeks 3. Cardiac surgery between 0- 4 weeks of age 4. Head circumference >= 31 cm Exclusion Criteria: 1. Patient with implants located in the intended area of the c-FLOW 3310-P sensor location. 2. Laceration of scalp injury at the intended area of the c-FLOW 3310-P sensors 3. Known brain malformation 4. Hydrocephalus 5. Resuscitation between the time of surgery and neurological outcome assessment |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Ornim Medical |
Israel,
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. — View Citation
Hori 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 Ana — View Citation
Massaro 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 Neurophys — View Citation
Rachelia, N. (2012). Non-Invasive Blood Flow Measurements Using Ultrasound Modulated Diffused Light. In Photons Plus Ultrasound: Imaging and Sensing 2012.
Tsalach 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
3 hours monitoring per day, for 4 days | |
Secondary | 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. |
3 hours monitoring per day, for 4 days |
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