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Urinary Creatinin/Protein Ratio in Preterms

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04608279
Acronym
PROTI-PREMA
Enrollment
124
Registered
2020-10-29
Start date
2017-01-31
Completion date
2020-01-31
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infant, Renal Failure

Brief 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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution in time of Ratio of proteinuria / creatininuriaDay 0, Day 2 or Day 3, Day 5 or Day 6, Week 2, Week 3, Week 4Ratio of proteinuria / creatinine to P1 (D0), P2 (D2 or D3), P3 (D5 or D6), P4 (W2), P5 (W3) and P6 (W4).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026