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

NCT ID: NCT06153771

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-16

Study Completion Date

2024-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Extremely Premature Newborn (Born Before 32 Weeks' Gestation)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Extremely premature newborn

(born before 32 weeks' gestation)

Collection of brain and kidney NIRS measurements

Intervention Type OTHER

(recorded continuously) by a person not involved in the study 30 minutes before echocardiography was performed

echocardiography

Intervention Type OTHER

on day 2, day 4 and day 7 of life

Interventions

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Collection of brain and kidney NIRS measurements

(recorded continuously) by a person not involved in the study 30 minutes before echocardiography was performed

Intervention Type OTHER

echocardiography

on day 2, day 4 and day 7 of life

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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TERNOY-Carriat 2023

Identifier Type: -

Identifier Source: org_study_id

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