Measuring urinary creatinine excretion in newborns
Definition of Urinary Creatinine Excretion Time in the Neonatal Period, in Full Term Newborns : a Prospective Monocentric Study
This study tests how well full-term newborns are able to clear creatinine from their urine in the first few days of life to help understand their kidney function better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 3 Days |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy, Lorraine) |
| Trial ID | NCT05813730 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficiency of urinary creatinine excretion in full-term newborns during the first days of life. It focuses on understanding renal function and physiology in neonates, particularly how creatinine is produced and cleared in this early period. By measuring urinary creatinine excretion, the study seeks to identify a specific postnatal age when renal function becomes efficient, which could enhance therapeutic management for infants at risk of nephrotoxicity. The study includes full-term newborns who meet specific health criteria and excludes those with significant clinical anomalies.
Who should consider this trial
Good fit: Ideal candidates for this study are full-term newborns who are healthy and have adapted well after birth.
Not a fit: Patients who may not benefit from this study include those with significant clinical anomalies or hemodynamic disorders.
Why it matters
Potential benefit: If successful, this study could improve the management of renal function in newborns, particularly in preventing nephrotoxicity.
How similar studies have performed: While this approach is novel in assessing urinary creatinine excretion in neonates, similar studies have shown the importance of understanding renal function in early life.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All full-term newborns (37WA or more) * From a physiological and spontaneous pregnancy * Good neonatal adaptation (Apgar 7 at 5 minutes of life) * Eutrophic (weight \> 10th percentile and \< 90th percentile) Exclusion Criteria: * Newborns for whom no urine sample is interpretable * Those with a significant clinical-biological anomaly * Neonates with hemodynamic disorders such as low blood pressure (median \< gestational age) or hypovolemia (shock, signs of dehydration, need for volume expansion) during the first 3 days of life
Where this trial is running
Nancy, Lorraine
- Maternite Regionale Universitaire CHRU NANCY — Nancy, Lorraine, France (Recruiting)
Study contacts
- Principal investigator: Nathalie LAMIREAU — CHRU Nancy
- Study coordinator: Jean-Michel HASCOET
- Email: j.hascoet@chru-nancy.fr
- Phone: 0383342934
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.