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

NCT02803671 | Completed

• 1 other identifier: PHRCN08-DR-KONGOLO
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosus, Patent

Keywords

preterm neonates; EEG-NIRS

Outcome Measures

Primary Outcomes (1)

• change in cerebral tissue oxygenation

  Day 3, Day 5 , Day 12, week 5

Study Arms (3)

patent ductus arteriosus

EXPERIMENTAL

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

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

without patent ductus arteriosus

EXPERIMENTAL

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

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

patent ductus arteriosus + cardiac or respiratory therapy

EXPERIMENTAL

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

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

Interventions

TFU-NIRS DEVICE

patent ductus arteriosus; patent ductus arteriosus + cardiac or respiratory therapy; without patent ductus arteriosus

NIRS DEVICE

patent ductus arteriosus; patent ductus arteriosus + cardiac or respiratory therapy; without patent ductus arteriosus

EEG DEVICE

patent ductus arteriosus; patent ductus arteriosus + cardiac or respiratory therapy; without patent ductus arteriosus

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Group of children :
• meeting the age criteria
• having a ductus arteriosus persistence.
• 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.
• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Guy KONGOLO, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 17, 2016
• Study Start: August 26, 2009
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

FR (1)