CompletedNot Applicable

Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy

France31 participantsStarted 2020-05-17

Plain-language 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.

Who can participate

Age range

1 Day – 8 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g. * presenting with perinatal asphyxia defined as combination of: * 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. Exclusion Criteria: * perinatal arterial ischemic stroke. * congenital neuro-metabolic disorder. * severe malformative abnormalities. * MRI contra-indication. * Poor understanding of the holders of parental authority

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical outcome

Timeframe: 3 months of life (Month 3)

Trial details

NCT IDNCT04325230

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-12

View on ClinicalTrials.gov More Neonatal Hypoxic Ischemic Encephalopathy trials

Who can participate

Age range

1 Day – 8 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.