Urinary Creatinine Excretion Time in the Neonatal Period

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy neonates

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

Group Type OTHER

urinary creatinine excretion measurement

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes