A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects

NCT03512613 | Unknown DMC

• 1 other identifier: RDCL- IL-SMC-021
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Congenital Heart Defect; Cerebrovascular Circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The correlation between Auto-regulation index and Neurological outcomes

  3 hours monitoring per day, for 4 days

Interventions

c-FLOW 3310-P DEVICE

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.

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with congenital heart disease scheduled for repair surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ornim Medical: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (5)

• 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.

  PMID: 24795612 RESULT

• 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 Neurophysiol. 2015 Aug;114(2):818-24. doi: 10.1152/jn.00353.2015. Epub 2015 Jun 10.

  PMID: 26063779 RESULT

• 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.

  PMID: 27571474 RESULT

• 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 Analg. 2015 Nov;121(5):1187-93. doi: 10.1213/ANE.0000000000000930.

  PMID: 26334746 RESULT

• Rachelia, N. (2012). Non-Invasive Blood Flow Measurements Using Ultrasound Modulated Diffused Light. In Photons Plus Ultrasound: Imaging and Sensing 2012.

  RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Omer Bar Yosef, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omer Bar Yosef, MD

CONTACT

+97252-6667344; Omer.BarYosef@sheba.health.gov.il

Oliana Vazhgovsky, BA

CONTACT

oliana.vazhgovsky@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: May 1, 2018
• Study Start: May 29, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)