Neonate Cerebral Activity in Immediate Post Partum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: electroencephalogram, oxymetry.
- Who it may be relevant to
- Registry conditions: Anoxia-Ischemia, Brain, Neonatal Encephalopathy. Basic parameters: 1 Minute — 15 Minutes · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
Overview
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.
Interventions
- Diagnostic test electroencephalogram
Within the 5 min after birth the electroencephalogram of the neonates will be recorded with the aid of a patch on the scalp - Diagnostic test oxymetry
Within the 5 min after birth the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp
Primary outcome measures
- Temporal correlation with EEG [Time frame: within the 5 minutes after birth]
- time-frequency correlation with EEG [Time frame: within the 5 minutes after birth]
- temporal correlation with NIRS signals [Time frame: within the 5 minutes after birth]
- time-frequency correlation with NIRS signals [Time frame: within the 5 minutes after birth]
Secondary outcome measures (1)
- Mode of delivery correlation with temporal and EEG data [Time frame: within the 5 minutes after birth]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04225975 · PI2019_843_0031