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Urinary Creatinine Excretion Time in the Neonatal Period (C-Rex)

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Renal Function

Treatments

Other: urinary creatinine excretion measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT05813730
RIPH 3 / 2022-A02613-40

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

Under 3 days old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Healthy neonates
Other group
Description:
A single arm evaluating creatinine renal excretion in healthy neonates' urine
Treatment:
Other: urinary creatinine excretion measurement

Trial contacts and locations

1

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Central trial contact

Jean-Michel HASCOET

Data sourced from clinicaltrials.gov

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