Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes

Summary

Perinatal asphyxia affects 3 to 8 newborns per 1,000 births, with moderate or severe anoxic-ischemic encephalopathy occurring in 0.5 to 1 per 1,000 births. Approximately 15 to 20% of affected newborns will die during the postnatal period, and 25 to 50% of those who survive will develop severe disabilities (epilepsy, cerebral palsy, sensory, behavioral, and psychiatric disorders).

In situations where there is a risk of perinatal asphyxia, the challenge for obstetricians is to choose between vaginal delivery or cesarean section and to determine the optimal time to induce labor in order to prevent brain damage.

Visual analysis of fetal heart rate (FHR) and uterine contraction signals by cardiotocography (CTG) is the gold standard method for monitoring fetal status and is one of the most common obstetric procedures. Numerous classifications have been proposed to classify FHR and predict neonatal outcomes. Unfortunately, they have a high rate of interobserver variability and low specificity for predicting neonatal complications.

The INSERM CIC-IT 1403 unit at Lille University Hospital has previously developed an innovative heart rate variability (HRV) analysis method for assessing autonomic nervous system activity. This technology has been adapted for assessing pain and well-being in adults and newborns (ANI and NIPE® monitors) and is now distributed in more than 70 countries worldwide. Numerous studies have demonstrated the ability of this HRV analysis to study the autonomic response to painful stimuli in adults, children, and newborns. More recently, we have studied the ability of our HRV analysis method to predict acidosis and have adapted it to obtain a fetal stress index (FSI).

As proof of concept for the effectiveness of FSI in treating acidosis and adverse neonatal outcomes (i.e., brain damage) has been established in an animal model as part of the PrevAP project, we hypothesize that FSI analysis could provide an effective means of assessing acidosis in human fetuses. Such real-time analysis of fetal HRV is now possible thanks to the TOCONAUTE system, whose safety and performance have been demonstrated in a previous study.

Conditions

• Obstetrics

Interventions

DEVICE

Recording of fetal and maternal heart rate

This study will be conducted in the maternity ward of the Lille's Jeanne de Flandre Hospital, Poissy's Hospital and Nantes University Hospital and during delivery, specifically in the operating room for delivery. The TOCONAUTE device will be placed on the mother's abdomen to record fetal heart rate. Recordings will be analyzed retrospectively using the ANI RELECTURE software to calculate the Fetal Stress Index (FSI). For each participant, the TOCONAUTE will remain in place on the abdomen. These procedures will not interfere with the standard clinical care provided to the pregnant woman.

Sponsors & Collaborators

• Clinical Investigation Centre for Innovative Technology Network

  collaborator NETWORK

• University Hospital, Lille

  lead OTHER

Principal Investigators

• Charles Garabédian, PH · CHU de Lille

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-03-31

Primary Completion

2028-03-31

Completion

2028-09-30