Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital (CAPNIRS)

September 19, 2025 updated by: Centre Hospitalier Universitaire Dijon

Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital: Exploratory Prospective, Monocentric, Observational, Descriptive Study

Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming. This test is usually carried out on days 2, 4 and 7 after birth.

NIRS (near-infrared spectroscopy) is a non-invasive method of monitoring tissue oxygen saturation using infrared light.

The aim of the study was to investigate an association between cerebral and renal NIRS data and ductus arteriosus status obtained by echocardiography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Extremely premature newborn (born before 32 weeks' gestation)

Description

Inclusion Criteria:

  • Parent who has agreed to participate in the study
  • Very premature newborn (born before 32 weeks' gestation)
  • Hospitalised in the Neonatal Intensive Care Unit at Dijon University Hospital
  • Before 48 hours of life

Exclusion Criteria:

  • Newborn with congenital heart disease
  • Newborn with a congenital renal anomaly
  • Newborn with polymalformative syndrome
  • Newborn with a skin anomaly
  • Newborn with severe circulatory failure unrelated to the ductus arteriosus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extremely premature newborn
(born before 32 weeks' gestation)
Other: Collection of brain and kidney NIRS measurements
(recorded continuously) by a person not involved in the study 30 minutes before echocardiography was performed
Other: echocardiography
on day 2, day 4 and day 7 of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ultrasound status of the ductus arteriosus
Time Frame: On day 2, day 4 and day 7 of life
(haemodynamically significant open, non-haemodynamically significant open, closed)
On day 2, day 4 and day 7 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Actual)

September 14, 2024

Study Completion (Actual)

September 14, 2024

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERNOY-Carriat 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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