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Urinary Creatinine Excretion Time in the Neonatal Period

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813730
Acronym
C-Rex
Enrollment
40
Registered
2023-04-14
Start date
2024-10-30
Completion date
2025-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Function

Keywords

Newborn, Renal Function, Physiology

Brief 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.

Interventions

OTHERurinary 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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal changes in urinary creatinine excretion in newbornsLongitudinal changes of collected samples from birth until discharge from the maternity hospital (i.e. from birth up to 72 hours postnatal age)Urine samples will be collected at each diaper change from birth until discharge

Countries

France

Contacts

Primary ContactJean-Michel HASCOET
j.hascoet@chru-nancy.fr0383342934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026