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

Recruiting

• Conditions: Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
• Interventions: Other: Collection of brain and kidney NIRS measurements; Other: echocardiography

• Registration Number: NCT06153771
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extremely premature newborn	Collection of brain and kidney NIRS measurements	(born before 32 weeks' gestation)
Extremely premature newborn	echocardiography	(born before 32 weeks' gestation)

Primary Outcome Measures

Name	Time	Method
The ultrasound status of the ductus arteriosus	On day 2, day 4 and day 7 of life	(haemodynamically significant open, non-haemodynamically significant open, closed)

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France