Urinary Creatinine Excretion Time in the Neonatal Period

Study Overview
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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.

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

Conditions
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Renal Function

Intervention / Treatment
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* Other: urinary creatinine excretion measurement


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy neonates<br>A single arm evaluating creatinine renal excretion in healthy neonates' urine | Other: urinary creatinine excretion measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Renal Function, Physiology