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NCT04608279 Clinical Trial

Urinary Creatinin/Protein Ratio in Preterms

Renal Failure Clinical Trial

— PROTI-PREMA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04608279
Other study ID # 2017/CHU/09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date January 2020

Study information
Verified date October 2020
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier de La Réunion Saint Pierre La Réunion

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evolution in time of Ratio of proteinuria / creatininuria Ratio of proteinuria / creatinine to P1 (D0), P2 (D2 or D3), P3 (D5 or D6), P4 (W2), P5 (W3) and P6 (W4). Day 0, Day 2 or Day 3, Day 5 or Day 6, Week 2, Week 3, Week 4
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