Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data (NNP-MULTIMODAL)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Ductus Arteriosus, Patent

Treatments: Device: NIRS; Device: EEG; Device: TFU-NIRS

Study type: Interventional

Funder types: Other

Identifiers

NCT02803671

PHRCN08-DR-KONGOLO

Details and patient eligibility

About

This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In this context, the investigators have developed know-how and specific acquisition and analysis tools (2 patents and several publications), allowing them to apply this know-how in children with patent ductus arteriosus.

Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of cardiac output towards the pulmonary circulation. The direct consequences of this shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other systemic organs are deprived of part of their normal perfusion and are subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical dysfunction, the analysis of which constitutes one of the objectives of this project.

Enrollment: 51 patients

Sex: All

Ages: Under 1 day old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Group of children :

   • meeting the age criteria
   • having a ductus arteriosus persistence.

2. Group of children :

   • meeting the age criteria
   • with persistent ductus arteriosus in the ultrasound examination
   • for which a cardiac or respiratory treatment has already been put in place.

3. normal group of children :

   • meeting the age criteria
   • without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

Exclusion criteria

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

51 participants in 3 patient groups

patent ductus arteriosus

Experimental group

Description:

ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)

Treatment:

Device: NIRS

Device: EEG

Device: TFU-NIRS

without patent ductus arteriosus

Experimental group

Description:

ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)

Treatment:

Device: NIRS

Device: EEG

Device: TFU-NIRS

patent ductus arteriosus + cardiac or respiratory therapy

Experimental group

Description:

ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)

Treatment:

Device: NIRS

Device: EEG

Device: TFU-NIRS