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PROTI-PREMA: Urinary Creatinin/Protein Ratio in Preterms

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Completed
CT.gov ID
NCT04608279
Collaborator
(none)
124
Enrollment
1
Location
36
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    124 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Evolution of the Proteinuria / Creatininuria Ratio in the First Month of Life in the Preterm Infant
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Jan 1, 2020
    Actual Study Completion Date :
    Jan 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Evolution in time of Ratio of proteinuria / creatininuria [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 2 Days
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier de La Réunion Saint Pierre La Réunion France 97448

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de la Réunion

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de la Réunion
    ClinicalTrials.gov Identifier:
    NCT04608279
    Other Study ID Numbers:
    • 2017/CHU/09
    First Posted:
    Oct 29, 2020
    Last Update Posted:
    Oct 29, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Oct 29, 2020