Urinary Creatinine Excretion Time in the Neonatal Period

NCT05813730 | Recruiting

• 1 other identifier: RIPH 3 / 2022-A02613-40
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Function

Keywords

Newborn; Renal Function; Physiology

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Healthy neonates

OTHER

A single arm evaluating creatinine renal excretion in healthy neonates' urine

Other: urinary creatinine excretion measurement

Interventions

urinary creatinine excretion measurement OTHER

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.

Healthy neonates

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

RECRUITING

Study Officials

• Nathalie LAMIREAU

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Michel HASCOET

CONTACT

0383342934; j.hascoet@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 14, 2023
• Study Start: October 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

FR (1)