Premature BirthPhase 4NCT00390065
Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
A Phase 4 study testing Nitric Oxide in people with Premature Birth, run by Maternite Regionale Universitaire at 2 sites in France.
Trial summary
Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Premature Birth
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2006to Jun 2009
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants included at birth in a randomized controlled trial using early nitric oxide therapy
Who cannot join
- Parental refusal
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternite Regionale Universitaire
Nancy, 54042
CHU Brabois
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide
Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.
Read the detailed description
Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. A two year follow-up in children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome.
- Conditions
- Premature Birth
- Being tested
- Nitric Oxide
- Keywords
- Follow-up, Premature infants, Nitric Oxide, Respiratory function testing, Neurodevelopmental outcomes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called Reference group (non hypoxemic infants)
Early low dose (5ppm) NO inhalation Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Hypoxemic Respiratory Failure treated by Nitric Oxide; Receives: Drug: Nitric Oxide |
| Control | Placebo comparator | Hypoxemic Respiratory Failure control (Placebo); Receives: Drug: Nitric Oxide |
| Reference | No intervention | Reference (Non hypoxemic respiratory failure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function testing
Measured: at 7 years postnatal age
Secondary outcomes (1)
Neurodevelopmental and Cognitive outcomes
Measured: at 7 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 posted19 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a follow-up study, at 6 years of age, of infants randomized in the neonatal period with one other group studied as a reference group (ie 3 groups)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternite Regionale Universitaire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Michel Hascoet, Maternite Regionale Universitaire
- Investigators
- Jean-Michel HASCOET, MD, Study director, University of NANCY, FranceIsabelle RM HAMON, MD, PhD, Principal investigator, Maternite Regionale Universitaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390065
- Sponsor's protocol ID
- MRAP060308
- Status last verified
- Mar 2017
- First submitted
- 17 Oct 2006
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hascoet JM, Fresson J, Claris O, Hamon I, Lombet J, Liska A, Cantagrel S, Al Hosri J, Thiriez G, Valdes V, Vittu G, Egreteau L, Henrot A, Buchweiller MC, Onody P. The safety and efficacy of nitric oxide therapy in premature infants. J Pediatr. 2005 Mar;146(3):318-23. doi: 10.1016/j.jpeds.2004.10.019.
PubMed 15756211Deforge H, Andre M, Hascoet JM, Toniolo AM, Demange V, Fresson J. [Cognitive development and attention performances at school age of "normal" prematurely born children]. Arch Pediatr. 2006 Sep;13(9):1195-201. doi: 10.1016/j.arcped.2006.05.015. Epub 2006 Jul 7. French.
PubMed 16824742Hamon I, Varechova S, Vieux R, Ioan I, Bonabel C, Schweitzer C, Hascoet JM, Marchal F. Exercise-induced bronchoconstriction in school-age children born extremely preterm. Pediatr Res. 2013 Apr;73(4 Pt 1):464-8. doi: 10.1038/pr.2012.202. Epub 2012 Dec 26.
PubMed 23269119
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide
- ClinicalTrials.gov ID
- NCT00390065
- Acronym / sponsor ID
- MRAP060308
- Conditions
- Premature Birth
- Keywords
- Follow-up, Premature infants, Nitric Oxide, Respiratory function testing, Neurodevelopmental outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Maternite Regionale UniversitaireUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Oct 2006 (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.
Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.
Detailed description
Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. A two year follow-up in children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a follow-up study, at 6 years of age, of infants randomized in the neonatal period with one other group studied as a reference group (ie 3 groups)
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Nitric OxideHypoxemic Respiratory Failure treated by Nitric Oxide; |
| Control | Placebo comparator | Drug: Nitric OxideHypoxemic Respiratory Failure control (Placebo); |
| Reference | No intervention | –Reference (Non hypoxemic respiratory failure) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants included at birth in a randomized controlled trial using early nitric oxide therapy
Key exclusion criteria (1 listed)
- Parental refusal
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 |
|---|---|---|
| Nitric OxideAlso: Reference group (non hypoxemic infants)Early low dose (5ppm) NO inhalation Placebo | Drug | Control, Study group |
Primary outcome
Pulmonary Function testing
Time frame: at 7 years postnatal age
1 secondary outcome
Neurodevelopmental and Cognitive outcomes
Time frame: at 7 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 22 Mar 2017.
- Background: PubMed 15756211Hascoet JM, Fresson J, Claris O, Hamon I, Lombet J, Liska A, Cantagrel S, Al Hosri J, Thiriez G, Valdes V, Vittu G, Egreteau L, Henrot A, Buchweiller MC, Onody P. The safety and efficacy of nitric oxide therapy in premature infants. J Pediatr. 2005 Mar;146(3):318-23. doi: 10.1016/j.jpeds.2004.10.019.
- Background: PubMed 16824742Deforge H, Andre M, Hascoet JM, Toniolo AM, Demange V, Fresson J. [Cognitive development and attention performances at school age of "normal" prematurely born children]. Arch Pediatr. 2006 Sep;13(9):1195-201. doi: 10.1016/j.arcped.2006.05.015. Epub 2006 Jul 7. French.
- Derived from this study: PubMed 23269119Hamon I, Varechova S, Vieux R, Ioan I, Bonabel C, Schweitzer C, Hascoet JM, Marchal F. Exercise-induced bronchoconstriction in school-age children born extremely preterm. Pediatr Res. 2013 Apr;73(4 Pt 1):464-8. doi: 10.1038/pr.2012.202. Epub 2012 Dec 26.
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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
Isabelle RM HAMON, MD, PhD principal investigator
Maternite Regionale Universitaire
2 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 Nitric Oxide in people with Premature Birth, run by Maternite Regionale Universitaire at 2 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Pulmonary Function testing (time frame: at 7 years postnatal 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 NCT00390065, which also lists 3 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 22 Mar 2017.