NCT04225975 Neonate Cerebral Activity in Immediate Post Partum
| NCT ID | NCT04225975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Anoxia-Ischemia, Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-03-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-03-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks. In this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.
Eligibility Criteria
Inclusion Criteria: * Full term neonates between 36 and 41 weeks Gestational Age Exclusion Criteria: * Premature neonates * Neonates of twin pregnancy * Suspicion of congenital malformation seen in antenatal ultrasound * Any pathology requiring pediatric care from birth * Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04225975 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 15 Minutes, studying Anoxia-Ischemia, Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04225975 currently recruiting?
Yes, NCT04225975 is actively recruiting participants. Contact the research team at fabrice.wallois@u-picardie.fr for enrollment information.
Where is the NCT04225975 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT04225975 clinical trial?
NCT04225975 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 60 participants.