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NCT05761548 Clinical Trial

Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging

Premature Birth Clinical Trial

Official title:
Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05761548
Other study ID # M2022211
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 19, 2022
Est. completion date July 1, 2023

Study information
Verified date February 2023
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Recently, with the development of perinatal medicine in China, the establishment of neonatal intensive care unit (NICU) and the improvement of respiratory support technology, the survival rate of preterm and term neonates has been significantly improved. However, the brain development of preterm neonates is incomplete compared with that of full-term neonates. Therefore, during the extrauterine cultivation of preterm neonates, clinical intervention should be carried out according to their brain development to achieve the same development status as that of full-term neonates. There are many clinical inspection methods to monitor the brain development of preterm neonates, such as EEG, functional near-infrared spectroscopy imaging, etc. However, these technologies cannot assess the brain development of premature infants systematically and completely. Because of the existence of neurovascular coupling, brain function and cerebral blood flow are closely related, so the detection of cerebral blood flow can reflect brain development and brain function. Ultrafast ultrasound power Doppler imaging technology is an emerging, real-time, high-resolution microvascular imaging technology. In this study, we first used ultrafast ultrasound power Doppler imaging technology to image the cerebral blood flow of preterm neonates at different gestational ages to evaluate the development of cerebral blood flow of preterm and term neonates and provide guidance for the clinical intervention of preterm neonates.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 1, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers
Gender All
Age group 24 Weeks to 40 Weeks
Eligibility Inclusion Criteria: - neonates without cerebral diseases Exclusion Criteria: - neonates with cerebral diseases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ultrafast ultrasound power Doppler imaging
ultrafast ultrasound power Doppler imaging for neonatal brain microvessels

Locations
Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intrauterine cerebral blood flow development of neonates 30 min
Primary Extrauterine cerebral blood flow development of neonates 30 min
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