NCT05761548

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intrauterine cerebral blood flow development of neonates

    30 min

  • Extrauterine cerebral blood flow development of neonates

    30 min

Study Arms (2)

mature

Diagnostic Test: ultrafast ultrasound power Doppler imaging

preterm

Diagnostic Test: ultrafast ultrasound power Doppler imaging

Interventions

ultrafast ultrasound power Doppler imaging for neonatal brain microvessels

maturepreterm

Eligibility Criteria

Age24 Weeks - 40 Weeks
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

From May 2022 to May 2023, newborns hospitalized in neonatal and NICU wards in the Peking University Third Hospital.

You may qualify if:

  • neonates without cerebral diseases

You may not qualify if:

  • neonates with cerebral diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

May 19, 2022

Primary Completion

May 15, 2023

Study Completion

July 1, 2023

Last Updated

March 9, 2023

Record last verified: 2023-02

Locations