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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-26

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Ductus Arteriosus, Patent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patent ductus arteriosus

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

Group Type EXPERIMENTAL

TFU-NIRS

Intervention Type DEVICE

NIRS

Intervention Type DEVICE

EEG

Intervention Type DEVICE

without patent ductus arteriosus

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

Group Type EXPERIMENTAL

TFU-NIRS

Intervention Type DEVICE

NIRS

Intervention Type DEVICE

EEG

Intervention Type DEVICE

patent ductus arteriosus + cardiac or respiratory therapy

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

Group Type EXPERIMENTAL

TFU-NIRS

Intervention Type DEVICE

NIRS

Intervention Type DEVICE

EEG

Intervention Type DEVICE

Interventions

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TFU-NIRS

Intervention Type DEVICE

NIRS

Intervention Type DEVICE

EEG

Intervention Type DEVICE

Eligibility Criteria

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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).