Extremely Premature Newborn (Born Before 32 Weeks' Gestation)CAPNIRSNCT06153771
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
An observational study of Extremely Premature Newborn (Born Before 32 Weeks' Gestation), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
- What is being tested?
- Collection of brain and kidney NIRS measurements and echocardiography
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 14 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Extremely premature newborn (born before 32 weeks' gestation)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Collection of brain and kidney NIRS measurements, echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of brain and kidney NIRS measurementsOther
(recorded continuously) by a person not involved in the study 30 minutes before echocardiography was performed
echocardiographyOther
on day 2, day 4 and day 7 of life
| Study group | Role | What they receive |
|---|---|---|
| Extremely premature newborn | (born before 32 weeks' gestation) Receives: Other: Collection of brain and kidney NIRS measurements; Other: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ultrasound status of the ductus arteriosus
(haemodynamically significant open, non-haemodynamically significant open, closed)
Measured: On day 2, day 4 and day 7 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start16 Oct 2023
- Primary completion14 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Premature Newborn (Born Before 32 Weeks' Gestation)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153771
- Sponsor's protocol ID
- TERNOY-Carriat 2023
- Acronym
- CAPNIRS
- Status last verified
- Sep 2025
- First submitted
- 23 Nov 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06153771
- Acronym / sponsor ID
- CAPNIRS / TERNOY-Carriat 2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely premature newborn | – | Other: Collection of brain and kidney NIRS measurements, Other: echocardiography(born before 32 weeks' gestation) |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Extremely premature newborn (born before 32 weeks' gestation)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of brain and kidney NIRS measurements(recorded continuously) by a person not involved in the study 30 minutes before echocardiography was performed | Other | Extremely premature newborn |
| echocardiographyon day 2, day 4 and day 7 of life | Other | Extremely premature newborn |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extremely Premature Newborn (Born Before 32 Weeks' Gestation), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ultrasound status of the ductus arteriosus (time frame: On day 2, day 4 and day 7 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.