Monitoring oxygen levels in very premature babies to assess heart vessel status
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
This study is testing if monitoring oxygen levels in the brains and kidneys of very premature babies can help doctors understand the condition of a heart vessel called the ductus arteriosus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | N/A to 48 Hours |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06153771 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between cerebral and renal oxygen saturation levels, measured using near-infrared spectroscopy (NIRS), and the status of the ductus arteriosus in extremely premature newborns. The study will involve collecting NIRS data alongside traditional echocardiography assessments, which are typically performed on days 2, 4, and 7 after birth. By utilizing a non-invasive method like NIRS, the study seeks to provide a more efficient way to monitor these vulnerable infants without the need for extensive positioning or time-consuming procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are very premature newborns born before 32 weeks' gestation who are hospitalized in the Neonatal Intensive Care Unit at Dijon University Hospital.
Not a fit: Patients with congenital heart disease, congenital renal anomalies, polymalformative syndromes, skin anomalies, or severe circulatory failure unrelated to the ductus arteriosus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques for very premature infants, potentially enhancing their care and outcomes.
How similar studies have performed: While the use of NIRS in monitoring oxygen levels is established, this specific approach to correlate it with ductus arteriosus status in extremely premature infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Ninon TERNOY
- Email: ninon.ternoy@chu-dijon.fr
- Phone: 03.80.29.34.62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.