Urinary Creatinin/Protein Ratio in Preterms

From the first days of life, the newborn presents a "physiological" proteinuria explained by the coexistence of a glomerular and tubular immaturity, all the more marked as the gestational age (GA) is weak. In the child term, proteinuria decreases the first month and its persistence is the marker of kidney damage. The persistence of proteinuria in preterm infants is also considered a marker of renal impairment; however, neither the "physiological" values nor the pattern of urinary excretion of proteins in the first month of life are known.

The proteinuria / creatininuria ratio is a validated indicator of proteinuria, as it is correlated with 24-hour urine proteinuria.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 day–2 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de La Réunion

Saint-Pierre, La Réunion, 97448, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Premature gestational age at birth superior or equal to 32 week of amenorrhea hospitalized in the intensive care unit or neonatal intensive care unit of the University Hospital of Reunion, southern site, Saint Pierre, in the first 24 hours of life
Informed consent form Legal representant

Exclusion criteria

Renal malformation known in antenatal

Treatment and study plan

Primary outcomes

Evolution in time of Ratio of proteinuria / creatininuria

Time frame: Day 0, Day 2 or Day 3, Day 5 or Day 6, Week 2, Week 3, Week 4

Ratio of proteinuria / creatinine to P1 (D0), P2 (D2 or D3), P3 (D5 or D6), P4 (W2), P5 (W3) and P6 (W4).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

Evolution of the Proteinuria / Creatininuria Ratio in the First Month of Life in the Preterm Infant

Acronym: PROTI-PREMA

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Oct 29, 2020
Registry last updated: Oct 29, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed