C-Rex: Urinary Creatinine Excretion Time in the Neonatal Period

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05813730

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Function	Other: urinary creatinine excretion measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy neonates A single arm evaluating creatinine renal excretion in healthy neonates' urine	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.

Arm

Intervention/Treatment

Other: Healthy neonates

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

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.

Outcome Measures

Primary Outcome Measures

Longitudinal changes in urinary creatinine excretion in newborns [Longitudinal 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Days

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine	France	54035

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Principal Investigator: Nathalie LAMIREAU, CHRU Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean-Michel HASCOET, Professor, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05813730

Other Study ID Numbers:

RIPH 3 / 2022-A02613-40

First Posted:

Apr 14, 2023

Last Update Posted:

Apr 14, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jean-Michel HASCOET, Professor, Central Hospital, Nancy, France

Newborn

Renal Function

Physiology

Study Results

No Results Posted as of Apr 14, 2023