Preterm InfantPROTI-PREMANCT04608279
Urinary Creatinin/Protein Ratio in Preterms
An observational study of Preterm Infant and Renal Failure, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 2 days
- Conditions the study is for
- Preterm Infant, Renal Failure
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Premature gestational age at birth superior or equal to 32 week of amenorrhea
Who may be able to join
- 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
Who cannot join
- Renal malformation known in antenatal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Preterm Infant, Renal Failure
- Medical subject headings
- Premature Birth, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0, Day 2 or Day 3, Day 5 or Day 6, Week 2, Week 3, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study startJan 2017
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608279
- Sponsor's protocol ID
- 2017/CHU/09
- Acronym
- PROTI-PREMA
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Proteinuria / Creatininuria Ratio in the First Month of Life in the Preterm Infant
- ClinicalTrials.gov ID
- NCT04608279
- Acronym / sponsor ID
- PROTI-PREMA / 2017/CHU/09
- Conditions
- Preterm Infant, Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature gestational age at birth superior or equal to 32 week of amenorrhea
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Renal malformation known in antenatal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Ratio of proteinuria / creatinine to P1 (D0), P2 (D2 or D3), P3 (D5 or D6), P4 (W2), P5 (W3) and P6 (W4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant and Renal Failure, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.