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

Not Applicable

Completed

• Conditions: Ductus Arteriosus, Patent
• Interventions: Device: TFU-NIRS; Device: NIRS; Device: EEG

• Registration Number: NCT02803671
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-26
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patent ductus arteriosus	TFU-NIRS	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
without patent ductus arteriosus	TFU-NIRS	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
patent ductus arteriosus + cardiac or respiratory therapy	NIRS	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
patent ductus arteriosus	EEG	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
without patent ductus arteriosus	NIRS	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
patent ductus arteriosus	NIRS	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
without patent ductus arteriosus	EEG	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
patent ductus arteriosus + cardiac or respiratory therapy	TFU-NIRS	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
patent ductus arteriosus + cardiac or respiratory therapy	EEG	ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)

Primary Outcome Measures

Name	Time	Method
change in cerebral tissue oxygenation	Day 3, Day 5 , Day 12, week 5

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France