Premature InfantsPhase 4NCT00217191
Ibuprofen and Renal Function in Premature Infants
A Phase 4 study testing Ibuprofen in people with Premature Infants and Patent Ductus Arteriosus, run by Maternite Regionale Universitaire at 3 sites in France.
Trial summary
Purpose of the study: 1. To evaluate renal function maturation within the first month of life in very premature infants. 2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life. Read more about this study
- Who is it for?
- Ages 0 years to 28 days
- Conditions the study is for
- Premature Infants, Patent Ductus Arteriosus
- What is being tested?
- Ibuprofen
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2004to Sep 2006
- Phase
- Phase 4
- 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 0 years to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational Age = 27 to 31 weeks
- Postnatal age < 48 hours
- Parental Consent Obtained
Who cannot join
- Renal malformation
- Urinary tract infection
- Renal Failure
- Pulmonary Hypertension at echocardiography
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
Purpose of the study:
- To evaluate renal function maturation within the first month of life in very premature infants.
- To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Read the detailed description
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants.
Purpose of the study:
- To evaluate renal function maturation within the first month of life in very premature infants.
- To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Population:
At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.
- Conditions
- Premature Infants, Patent Ductus Arteriosus
- Being tested
- Ibuprofen
- Keywords
- Premature Infants, Patent ductus arteriosus, Renal function, Ibuprofen
- Medical subject headings
- Premature Birth, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine Clearance on day seven postnatally
Secondary outcomes (5)
Rate of ductus closure after treatment
Mortality
Rate of necrotizing enterocolitis
Rate and severity of Intraventricular Hemorrhage
Renal function maturation over 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Maternite Regionale Universitaire
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France, Ministere de la Sante et de la Protection Sociale, France
- Investigators
- Jean-Michel HASCOET, MD, Study director, University of Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217191
- Sponsor's protocol ID
- MRAP040833
- Other IDs
- PHRC2004:17-06
- Status last verified
- Sep 2006
- First submitted
- 14 Sep 2005
- Last updated
- 19 Sep 2006
- Results posted
- No
Publications
Gournay V, Roze JC, Kuster A, Daoud P, Cambonie G, Hascoet JM, Chamboux C, Blanc T, Fichtner C, Savagner C, Gouyon JB, Flurin V, Thiriez G. Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2004 Nov 27-Dec 3;364(9449):1939-44. doi: 10.1016/S0140-6736(04)17476-X.
PubMed 15567009Desandes R, Jellimann JM, Rouabah M, Haddad F, Desandes E, Boubred F, Semama DS, Vieux R, Hascoet JM. Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction. Pediatr Crit Care Med. 2012 May;13(3):324-7. doi: 10.1097/PCC.0b013e31822882b5.
PubMed 21760564Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010 May;125(5):e1186-92. doi: 10.1542/peds.2009-1426. Epub 2010 Apr 5.
PubMed 20368313Vieux R, Desandes R, Boubred F, Semama D, Guillemin F, Buchweiller MC, Fresson J, Hascoet JM. Ibuprofen in very preterm infants impairs renal function for the first month of life. Pediatr Nephrol. 2010 Feb;25(2):267-74. doi: 10.1007/s00467-009-1349-9. Epub 2009 Nov 10.
PubMed 19902266
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen and Renal Function in Premature Infants
- ClinicalTrials.gov ID
- NCT00217191
- Acronym / sponsor ID
- MRAP040833
- Conditions
- Premature Infants, Patent Ductus Arteriosus
- Keywords
- Premature Infants, Patent ductus arteriosus, Renal function, Ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Maternite Regionale UniversitaireUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France, Ministere de la Sante et de la Protection Sociale, France
- Study start
- Sep 2004
- Study completion
- Sep 2006
- First posted
- 22 Sep 2005 (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 renal function maturation within the first month of life in very premature infants.
- To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Detailed description
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants.
Purpose of the study:
- To evaluate renal function maturation within the first month of life in very premature infants.
- To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Population:
At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational Age = 27 to 31 weeks
- Postnatal age < 48 hours
- Parental Consent Obtained
Key exclusion criteria (4 listed)
- Renal malformation
- Urinary tract infection
- Renal Failure
- Pulmonary Hypertension at echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen | Drug | – |
Primary outcome
Creatinine Clearance on day seven postnatally
5 secondary outcomes
Rate of ductus closure after treatment
Mortality
Rate of necrotizing enterocolitis
Rate and severity of Intraventricular Hemorrhage
Renal function maturation over 28 days
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 19 Sep 2006.
- Background: PubMed 15567009Gournay V, Roze JC, Kuster A, Daoud P, Cambonie G, Hascoet JM, Chamboux C, Blanc T, Fichtner C, Savagner C, Gouyon JB, Flurin V, Thiriez G. Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2004 Nov 27-Dec 3;364(9449):1939-44. doi: 10.1016/S0140-6736(04)17476-X.
- Derived from this study: PubMed 21760564Desandes R, Jellimann JM, Rouabah M, Haddad F, Desandes E, Boubred F, Semama DS, Vieux R, Hascoet JM. Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction. Pediatr Crit Care Med. 2012 May;13(3):324-7. doi: 10.1097/PCC.0b013e31822882b5.
- Derived from this study: PubMed 20368313Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010 May;125(5):e1186-92. doi: 10.1542/peds.2009-1426. Epub 2010 Apr 5.
- Derived from this study: PubMed 19902266Vieux R, Desandes R, Boubred F, Semama D, Guillemin F, Buchweiller MC, Fresson J, Hascoet JM. Ibuprofen in very preterm infants impairs renal function for the first month of life. Pediatr Nephrol. 2010 Feb;25(2):267-74. doi: 10.1007/s00467-009-1349-9. Epub 2009 Nov 10.
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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 study director
University of Nancy, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen in people with Premature Infants and Patent Ductus Arteriosus, run by Maternite Regionale Universitaire 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 3 inclusion and 4 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 19 Sep 2006. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 on day seven postnatally. 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 NCT00217191, which also lists 4 linked publications.
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 19 Sep 2006; AzTrials last refreshed its copy on 2 Nov 2026.