Urinary Creatinin/Protein Ratio in Preterms

NCT04608279 | Completed

• 1 other identifier: 2017/CHU/09
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Renal malformation known in antenatal

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Centre Hospitalier de La Réunion

Saint-Pierre, La Réunion, 97448, France

Location

MeSH Terms

Conditions

Premature Birth; Renal Insufficiency

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 29, 2020
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)