## Protocol Section
### Identification Module
**NCT ID:** NCT04608279

**Acronym:** PROTI-PREMA

**Brief Title:** Urinary Creatinin/Protein Ratio in Preterms

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

#### Organization Study ID Info
**ID:** 2017/CHU/09
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de la Réunion
### Status Module
#### Completion Date
**Date:** 2020-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-10-29

**Type:** ACTUAL

**Last Update Submit Date:** 2020-10-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-01

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01

**Type:** ACTUAL

**Status Verified Date:** 2020-10

#### Study First Post Date
**Date:** 2020-10-29
**Type:** ACTUAL
**Study First Submit Date:** 2019-10-08
**Study First Submit QC Date:** 2020-10-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de la Réunion

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Preterm Infant

- Renal Failure

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 124

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Ratio of proteinuria / creatinine to P1 (D0), P2 (D2 or D3), P3 (D5 or D6), P4 (W2), P5 (W3) and P6 (W4).

**Measure:** Evolution in time of Ratio of proteinuria / creatininuria

**Time Frame:** Day 0, Day 2 or Day 3, Day 5 or Day 6, Week 2, Week 3, Week 4

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 2 Days

**Minimum Age:** 1 Day

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Premature gestational age at birth superior or equal to 32 week of amenorrhea

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Saint Pierre

**Country:** France

**Facility:** Centre Hospitalier de La Réunion

**State:** La Réunion

**Zip:** 97448

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Preterm

- ID: M14368

- Name: Proteinuria

- Relevance: LOW

- As Found: Unknown

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-24
