Neonate Cerebral Activity in Immediate Post Partum (POSTPARTUM)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Anoxia-Ischemia, Brain; Neonatal Encephalopathy

Treatments: Diagnostic Test: oxymetry; Diagnostic Test: electroencephalogram

Study type: Interventional

Funder types: Other

Identifiers

NCT04225975

PI2019_843_0031

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 15 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)