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CAPNIRS: 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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT06153771
Collaborator
(none)
140
Enrollment
1
Location
24.5
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Collection of brain and kidney NIRS measurements
  • Other: echocardiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Oct 16, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 48 Hours
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT06153771
Other Study ID Numbers:
  • TERNOY-Carriat 2023
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Premature Birth
Ductus Arteriosus, Patent

Study Results

No Results Posted as of Dec 1, 2023