Prematurity of FetusSUIVIREINNCT00817921
Effect of Prematurity on Renal Function in 5 Years Old Children
An observational study of Prematurity of Fetus, run by Jean Michel Hascoet at 3 sites in France.
Trial summary
Purpose of the study: 1. To evaluate the effect of prematurity on renal function in 5 years old children 2. To compare former premature children treated by ibuprofen in the neonatal period to controls Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity of Fetus
- How many people
- 168 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2008to Dec 2013
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children from a previous trial followed at 3, 4 and 5 years of age
Who may be able to join
- Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191)
Who cannot join
- lack of parental consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU
Dijon, 21079
AP-HM (Néonatologie)
Marseille, 13000
Maternite Regionale Universitaire
Nancy, 54042
About this study
Official title: Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls
Purpose of the study:
- To evaluate the effect of prematurity on renal function in 5 years old children
- To compare former premature children treated by ibuprofen in the neonatal period to controls
- Conditions
- Prematurity of Fetus
- Keywords
- premature renal function, ibuprofen, blood pressure, Renal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | former premature children treated by ibuprofen | |
| 2 | former premature children not treated by ibuprofen | |
| 3 | former term children (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine clearance
Measured: 5 years of age
Secondary outcomes (7)
Growth
Measured: at 3 years of age
Blood Pressure
Measured: 5 years of age
Hemodynamic tolerance to mild exercise
Measured: 3 years of age
Growth
Measured: 4 years of age
Growth
Measured: 5 years of age
Hemodynamic tolerance to mild exercise
Measured: 4 years of age
Hemodynamic tolerance to mild exercise
Measured: 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prematurity of FetusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Michel Hascoet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean Michel Hascoet, Maternite Regionale Universitaire
- Investigators
- Jean-Michel HASCOET, MD, Principal investigator, Maternite Regionale Universitaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817921
- Sponsor's protocol ID
- MRU-07-11
- Acronym
- SUIVIREIN
- Status last verified
- Feb 2014
- First submitted
- 6 Jan 2009
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vieux R, Hascoet JM, Franck P, Guillemin F. Increased albuminuria in 4-year-old preterm-born children with normal height. J Pediatr. 2012 Jun;160(6):923-8.e1. doi: 10.1016/j.jpeds.2011.12.005. Epub 2012 Jan 18.
PubMed 22261507
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls
- ClinicalTrials.gov ID
- NCT00817921
- Acronym / sponsor ID
- SUIVIREIN / MRU-07-11
- Conditions
- Prematurity of Fetus
- Keywords
- premature renal function, ibuprofen, blood pressure, Renal function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Jean Michel HascoetUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jan 2009 (estimated)
- 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.
Purpose of the study:
- To evaluate the effect of prematurity on renal function in 5 years old children
- To compare former premature children treated by ibuprofen in the neonatal period to controls
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –former premature children treated by ibuprofen |
| 2 | – | –former premature children not treated by ibuprofen |
| 3 | – | –former term children (control) |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children from a previous trial followed at 3, 4 and 5 years of age
Key inclusion criteria (1 listed)
- Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191)
Key exclusion criteria (1 listed)
- lack of parental consent
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
Creatinine clearance
Time frame: 5 years of age
7 secondary outcomes
Growth
Time frame: at 3 years of age
Blood Pressure
Time frame: 5 years of age
Hemodynamic tolerance to mild exercise
Time frame: 3 years of age
Growth
Time frame: 4 years of age
Growth
Time frame: 5 years of age
Hemodynamic tolerance to mild exercise
Time frame: 4 years of age
Hemodynamic tolerance to mild exercise
Time frame: 5 years of age
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 5 Feb 2014.
- Derived from this study: PubMed 22261507Vieux R, Hascoet JM, Franck P, Guillemin F. Increased albuminuria in 4-year-old preterm-born children with normal height. J Pediatr. 2012 Jun;160(6):923-8.e1. doi: 10.1016/j.jpeds.2011.12.005. Epub 2012 Jan 18.
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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.
Jean-Michel HASCOET, MD principal investigator
Maternite Regionale Universitaire
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity of Fetus, run by Jean Michel Hascoet at 3 sites 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 1 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 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Creatinine clearance (time frame: 5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00817921, which also lists 1 linked publication.
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 5 Feb 2014.