Prematurity, Respiratory Distress Syndrome,HypoxemiaPhase 3NCT00152542
Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
A Phase 3 study testing Inhaled nitric oxide in people with Prematurity, Respiratory Distress Syndrome,Hypoxemia, run by University of Chicago at 1 site in United States.
Trial summary
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome,Hypoxemia
- What is being tested?
- Inhaled nitric oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2006
- Phase
- Phase 3
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who participated in NOVA study and are of school age
Who cannot join
- Children who participated in NOVA study but deceased post discharge
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago, Comer Children's Hospital,
Chicago, Illinois, 60637
About this study
Official title: Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.
Read the detailed description
Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).
- Being tested
- Inhaled nitric oxide, Placebo
- Keywords
- Inhaled nitric oxide,, Lung recruitment,, Ventilatory approach,, Neurodevelopmental outcomes,, School age children
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitric oxideDrug
1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
PlaceboDrug
No iNO given for days 1-7
| Study group | Role | What they receive |
|---|---|---|
| Inhaled nitric oxide | Experimental | Not described Receives: Drug: Inhaled nitric oxide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life
Measured: 4-7 years of age (between 2005-2006)
Secondary outcomes (1)
Examine health status at early school-age
Measured: 4-7 years of age (between 2005-2006)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionSep 2006
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, Respiratory Distress Syndrome,HypoxemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Michael D Schreiber, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152542
- Sponsor's protocol ID
- 9549 (temp19)
- Other IDs
- 29078
- Status last verified
- Mar 2009
- First submitted
- 8 Sep 2005
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patrianakos-Hoobler AI, Marks JD, Msall ME, Huo D, Schreiber MD. Safety and efficacy of inhaled nitric oxide treatment for premature infants with respiratory distress syndrome: follow-up evaluation at early school age. Acta Paediatr. 2011 Apr;100(4):524-8. doi: 10.1111/j.1651-2227.2010.02077.x. Epub 2010 Dec 1.
PubMed 21054515
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
- ClinicalTrials.gov ID
- NCT00152542
- Acronym / sponsor ID
- 9549 (temp19)
- Keywords
- Inhaled nitric oxide,, Lung recruitment,, Ventilatory approach,, Neurodevelopmental outcomes,, School age children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 9 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.
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.
Detailed description
Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled nitric oxide | Experimental | Drug: Inhaled nitric oxide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who participated in NOVA study and are of school age
Key exclusion criteria (1 listed)
- Children who participated in NOVA study but deceased post discharge
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 |
|---|---|---|
| Inhaled nitric oxide1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7 | Drug | Inhaled nitric oxide |
| PlaceboNo iNO given for days 1-7 | Drug | Placebo |
Primary outcome
Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life
Time frame: 4-7 years of age (between 2005-2006)
1 secondary outcome
Examine health status at early school-age
Time frame: 4-7 years of age (between 2005-2006)
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 12 Jun 2013.
- Derived from this study: PubMed 21054515Patrianakos-Hoobler AI, Marks JD, Msall ME, Huo D, Schreiber MD. Safety and efficacy of inhaled nitric oxide treatment for premature infants with respiratory distress syndrome: follow-up evaluation at early school age. Acta Paediatr. 2011 Apr;100(4):524-8. doi: 10.1111/j.1651-2227.2010.02077.x. Epub 2010 Dec 1.
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.
Michael D Schreiber, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled nitric oxide in people with Prematurity, Respiratory Distress Syndrome,Hypoxemia, run by University of Chicago at 1 site in United States.
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 12 Jun 2013. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life (time frame: 4-7 years of age (between 2005-2006)). 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 NCT00152542, 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 12 Jun 2013.