Miscellaneous Disorders in the Fetus or NewbornCONCT01818843
The Safety and Adverse Reaction Study of Neonatal to Inhaled Carbon Monoxide
A study testing Inhaled Carbon Monoxide in people with Miscellaneous Disorders in the Fetus or Newborn, run by CAN WANG at 1 site in China.
Trial summary
Based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .Phase 1 Study as a foundation for the further test is, the safety and Adverse reaction study of newborn to inhaled CO Read more about this study
- Who is it for?
- Ages 1 minute to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Miscellaneous Disorders in the Fetus or Newborn
- What is being tested?
- Inhaled Carbon Monoxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Dec 2013
- Phase
- Interventional
- 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 minute to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The newborn whose physiological function is healthy or close to healthy
Who cannot join
- Clinical considerations cannot survive or no treatment value of newborn Diagnosis of congenital or hereditary diseases, or children with heart diseaseCentral pulmonary vascular malformations in children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension
Based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .Phase 1 Study as a foundation for the further test is, the safety and Adverse reaction study of newborn to inhaled CO
Read the detailed description
Previous studies have demonstrated that, carbon monoxide has showed the effectiveness such as in inflammation ,apoptosis as well as relaxation of smooth muscle of the body. Now we have a hypothesis to use carbon monoxide in pulmonary hypertension of the newborns, to observe whether it will decrease pulmonary artery hypertension on newborns. Phase 1 study is ,the safety and Adverse reaction study of newborn to inhaled CO , after this,we can master the application of carbon monoxide dose
- Being tested
- Inhaled Carbon Monoxide
- Keywords
- Carbon monoxide, safety, Adverse Reaction, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Carbon MonoxideOther
Inhaled Carbon Monoxide in newborn
| Study group | Role | What they receive |
|---|---|---|
| Safety and Adverse Reaction in CO | Experimental | Inhaled Carbon Monoxide Receives: Other: Inhaled Carbon Monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscellaneous Disorders in the Fetus or NewbornStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAN WANG
- Sponsor type
- University, hospital or other
- Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Responsible party
- Sponsor-investigator, CAN WANG, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818843
- Sponsor's protocol ID
- DapingH 021
- Acronym
- CO
- Status last verified
- Apr 2012
- First submitted
- 26 Feb 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01818843
- Acronym / sponsor ID
- CO / DapingH 021
- Keywords
- Carbon monoxide, safety, Adverse Reaction, newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CAN WANGUniversity, hospital or other
- Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Mar 2013 (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.
Based on the study about carbon monoxide in human inflammatory and other beneficial physiological function , now we'll be going to research its application in neonates .Phase 1 Study as a foundation for the further test is, the safety and Adverse reaction study of newborn to inhaled CO
Detailed description
Previous studies have demonstrated that, carbon monoxide has showed the effectiveness such as in inflammation ,apoptosis as well as relaxation of smooth muscle of the body. Now we have a hypothesis to use carbon monoxide in pulmonary hypertension of the newborns, to observe whether it will decrease pulmonary artery hypertension on newborns. Phase 1 study is ,the safety and Adverse reaction study of newborn to inhaled CO , after this,we can master the application of carbon monoxide dose
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and Adverse Reaction in CO | Experimental | Other: Inhaled Carbon MonoxideInhaled Carbon Monoxide |
Who may qualify
- Ages
- 1 minute to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The newborn whose physiological function is healthy or close to healthy
Key exclusion criteria (1 listed)
- Clinical considerations cannot survive or no treatment value of newborn Diagnosis of congenital or hereditary diseases, or children with heart diseaseCentral pulmonary vascular malformations in children
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 Carbon MonoxideInhaled Carbon Monoxide in newborn | Other | Safety and Adverse Reaction in CO |
Primary outcome
Number of participants with adverse events
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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?
A study testing Inhaled Carbon Monoxide in people with Miscellaneous Disorders in the Fetus or Newborn, run by CAN WANG at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 28 Mar 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 China. 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?
Results are not available in the source record.
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?
Number of participants with adverse events (time frame: up to 1 month). 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 28 Mar 2013.