Urinary Creatinine Excretion Time in the Neonatal Period
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: urinary creatinine excretion measurement.
- Who it may be relevant to
- Registry conditions: Renal Function. Basic parameters: up to 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Definition of Urinary Creatinine Excretion Time in the Neonatal Period, in Full Term Newborns : a Prospective Monocentric Study
Overview
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
- 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.
Primary outcome measures
- Longitudinal changes in urinary creatinine excretion in newborns [Time frame: Longitudinal changes of collected samples from birth until discharge from the maternity hospital (i.e. from birth up to 72 hours postnatal age)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Maternite Regionale Universitaire CHRU NANCY — Nancy
Identifiers
NCT: NCT05813730 · RIPH 3 / 2022-A02613-40