NCT04325230

Completed

Prognostic Value of Arterial Spin Labeling Brain Perfusion M...

University Hospital, Bordeaux Source

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Other study identifiers

Sponsor study identifier

CHUBX 2020/01

Secondary identifiers

2020-A00299-30

OTHER · ANSM

Study Type

interventional

Actual enrollment (reported)

31

Locations

1 country

Sites

1

Timeline

Study Start

May 17, 2020

Actual (reported)

Primary Completion

January 12, 2023

Actual (reported)

Study Completion

January 12, 2023

Actual (reported)

Brief Summary

The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 31 participants
Study completion date: January 12, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 16, 2020
Actual (reported)
First Posted
March 27, 2020
Actual (reported)
Study Start
May 17, 2020
Actual (reported)
Primary Completion
January 12, 2023
Actual (reported)
Study Completion
January 12, 2023
Actual (reported)

Last Updated: May 29, 2026
Status Verified: April 2023
Last Update Submitted: May 28, 2026

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic-ischemic encephalopathyNeonatePerfusionMRIArterial Spin Labeling

Outcome Measures

Primary Outcomes (1)

Clinical outcome
judged as favorable, or as adverse in case of death or cerebral palsy
3 months of life (Month 3)

Secondary Outcomes (4)

Clinical outcome
Month 6, Month 12
Prognostic performances of ASL
Baseline
Quality of ASL sequences
Baseline
Inter-observer agreement of the interpretation of the perfusion data
Baseline

Study Arms (1)

Arterial Spin Labeling sequence

EXPERIMENTAL

ASL sequence added to the usual care brain MRI

Device: Arterial Spin Labeling sequence

Interventions

Arterial Spin Labeling sequenceDevice

ASL sequence added to the usual care brain MRI

Arterial Spin Labeling sequence

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Day - 8 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g.
presenting with perinatal asphyxia defined as combination of:

Sponsors & Collaborators

University Hospital, Bordeaux
Otherlead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

31 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 27, 2020

Study Start

May 17, 2020

Actual (reported)

Primary Completion

NCT05648812

Neonatal Brain Ultrasound With CEUS and Elastography

Phase 3Recruiting

NCT06746532

Intranasal Breast Milk Therapy in HIE

Early Phase 1Recruiting

an acute perinatal event (such as placental abruption, cord prolapse, and/or severe foetal heart rate abnormalities);

and at least one of the following criteria:

Apgar score ≤ 5 at 10 minutes of life,

mask ventilation or intubation at 10 minutes of life,

metabolic acidosis defined as pH \< 7 or base deficit ≥ 16 mmol/L or lactates ≥ 11 mmol/L within the first 60 minutes of life on cord or other arterial venous or capillary blood sample.

patient treated or not with therapeutic hypothermia for 72 hours.

affiliated patient or beneficiary of a social security scheme.

informed and signed parental consent.

You may not qualify if:

perinatal arterial ischemic stroke.
congenital neuro-metabolic disorder.
severe malformative abnormalities.
MRI contra-indication.
Poor understanding of the holders of parental authority

Contact the study team to confirm eligibility.

January 12, 2023

Actual (reported)

Study Completion

January 12, 2023

Actual (reported)

Last Updated

May 29, 2026

Record last verified: 2023-04

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04325230
Data provider: ClinicalTrials.gov
Source updated: 2026-05-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:10 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Arterial Spin Labeling sequence

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations