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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)

Primary Purpose

Ductus Arteriosus, Patent

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TFU-NIRS
NIRS
EEG
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ductus Arteriosus, Patent focused on measuring preterm neonates, EEG-NIRS

Eligibility Criteria

undefined - 1 Day (Child)All SexesAccepts 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:

-

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

patent ductus arteriosus

without patent ductus arteriosus

patent ductus arteriosus + cardiac or respiratory therapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

change in cerebral tissue oxygenation

Secondary Outcome Measures

Full Information

First Posted
June 10, 2016
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02803671
Brief Title
Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
Acronym
NNP-MULTIMODAL
Official Title
Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 26, 2009 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus, Patent
Keywords
preterm neonates, EEG-NIRS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patent ductus arteriosus
Arm Type
Experimental
Arm Description
ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
Arm Title
without patent ductus arteriosus
Arm Type
Experimental
Arm Description
ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
Arm Title
patent ductus arteriosus + cardiac or respiratory therapy
Arm Type
Experimental
Arm Description
ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
Intervention Type
Device
Intervention Name(s)
TFU-NIRS
Intervention Type
Device
Intervention Name(s)
NIRS
Intervention Type
Device
Intervention Name(s)
EEG
Primary Outcome Measure Information:
Title
change in cerebral tissue oxygenation
Time Frame
Day 3, Day 5 , Day 12, week 5

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy KONGOLO, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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