Premature BirthNCT05761548
Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging
An observational study of Premature Birth, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 24 to 40 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- ultrafast ultrasound power Doppler imaging
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 weeks
- All sexes
- Child
Study population: From May 2022 to May 2023, newborns hospitalized in neonatal and NICU wards in the Peking University Third Hospital.
Who may be able to join
- neonates without cerebral diseases
Who cannot join
- neonates with cerebral diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yunfeng Liu, Phd, 86-13520694100, liuyunfeng96@163.com
About this study
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.
- Conditions
- Premature Birth
- Being tested
- ultrafast ultrasound power Doppler imaging
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrafast ultrasound power Doppler imagingDiagnostic test
ultrafast ultrasound power Doppler imaging for neonatal brain microvessels
| Study group | Role | What they receive |
|---|---|---|
| mature | Not described Receives: Diagnostic Test: ultrafast ultrasound power Doppler imaging | |
| preterm | Not described Receives: Diagnostic Test: ultrafast ultrasound power Doppler imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine cerebral blood flow development of neonates
Measured: 30 min
Extrauterine cerebral blood flow development of neonates
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start19 May 2022
- Primary completion15 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yunfeng, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761548
- Sponsor's protocol ID
- M2022211
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging
- ClinicalTrials.gov ID
- NCT05761548
- Acronym / sponsor ID
- M2022211
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mature | – | Diagnostic Test: ultrafast ultrasound power Doppler imaging |
| preterm | – | Diagnostic Test: ultrafast ultrasound power Doppler imaging |
Who may qualify
- Ages
- 24 to 40 weeks
- Sex
- All
- Age groups
- Child
- Study population
- From May 2022 to May 2023, newborns hospitalized in neonatal and NICU wards in the Peking University Third Hospital.
Key inclusion criteria (1 listed)
- neonates without cerebral diseases
Key exclusion criteria (1 listed)
- neonates with cerebral diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrafast ultrasound power Doppler imagingultrafast ultrasound power Doppler imaging for neonatal brain microvessels | Diagnostic test | mature, preterm |
Primary outcome
Intrauterine cerebral blood flow development of neonates
Time frame: 30 min
Extrauterine cerebral blood flow development of neonates
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine cerebral blood flow development of neonates (time frame: 30 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.