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

Ductus Arteriosus, Patent Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803671
• Other study ID #: PHRCN08-DR-KONGOLO
• Status: Completed
• Phase: N/A
• Start date: August 26, 2009
• Est. completion date: February 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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:

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

Device:
• TFU-NIRS

• NIRS

• EEG

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cerebral tissue oxygenation		Day 3, Day 5 , Day 12, week 5