Urinary Creatinin/Protein Ratio in Preterms (PROTI-PREMA)

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Preterm Infant

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• France
  • La Réunion
    • Saint Pierre, La Réunion, France, 97448
      • Centre hospitalier de la Réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature gestational age at birth superior or equal to 32 week of amenorrhea

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2017/CHU/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No