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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06153771
Acronym
CAPNIRS
Enrollment
26
Registered
2023-12-01
Start date
2023-10-16
Completion date
2024-09-14
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremely Premature Newborn (Born Before 32 Weeks' Gestation)

Brief summary

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.

Interventions

OTHERCollection of brain and kidney NIRS measurements

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

OTHERechocardiography

on day 2, day 4 and day 7 of life

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The ultrasound status of the ductus arteriosusOn day 2, day 4 and day 7 of life(haemodynamically significant open, non-haemodynamically significant open, closed)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026