Chu Dijon Bourgogne
Dijon, 21000, France
Completed
NCT Number: NCT06153771
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
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.
Completed
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Notify MeKey information
Age range
Up to 48 hour
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Collection of brain and kidney NIRS measurements
Other(recorded continuously) by a person not involved in the study 30 minutes before echocardiography was performed
echocardiography
Otheron day 2, day 4 and day 7 of life
Primary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire Dijon
Other
Registry information
Official study title
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
Acronym: CAPNIRS
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Dec 1, 2023
- Registry last updated
- Sep 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.