Urinary Creatinine Excretion Time in the Neonatal Period

Renal Function Clinical Trial

— C-Rex  

Official title:

Definition of Urinary Creatinine Excretion Time in the Neonatal Period, in Full Term Newborns : A Prospective Monocentric Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05813730
• Other study ID #: RIPH 3 / 2022-A02613-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Jean-Michel HASCOET
• Phone: 0383342934
• Email: j.hascoet[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Newborn's renal function is difficult to assess and its physiology during the first days of life is still incompletely known. Studies suggest that the newborn almost completely reabsorbs creatinine during the first 48 to 72 hours of life, while at the same time it continues to produce its own creatinine. Therefore, the initial stock of creatinine at birth still increases through this production and the non or weak clearance. A better knowledge of renal physiopathology in newborns would allow to improve the therapeutic management of the infants, particularly in case of potential nephrotoxicity. No study has attempted to assess the increase in urinary creatinine excretion in neonates from a given time.

Objectives: To show when urinary creatinine excretion in newborns is efficient. Results: this study mightr show an inflection point in urinary creatinine excretion illustrating the postnatal age when renal function becomes efficient.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Renal Function

Intervention

Other:
• urinary creatinine excretion measurement
Urine samples will be collected up to 6 times a day from birth until discharge from the maternity hospital, to analyze the kinetics of creatinuria.

Locations

Country	Name	City	State
France	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal changes in urinary creatinine excretion in newborns	Urine samples will be collected at each diaper change from birth until discharge	Longitudinal changes of collected samples from birth until discharge from the maternity hospital (i.e. from birth up to 72 hours postnatal age)