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NCT Number: NCT05813730

Urinary Creatinine Excretion Time in the Neonatal Period

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.

Recruiting

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Key information

Conditions

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Location status: Recruiting

Location contact

Jean-Michel HASCOET, MD

CONTACT

+33 383 342 934

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urinary creatinine excretion measurement

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.

Primary outcomes

  1. 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)

    Urine samples will be collected at each diaper change from birth until discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Michel HASCOET

CONTACT

[email protected]

0383342934

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: C-Rex

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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