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The Safety and Adverse Reaction Study of Neonatal to Inhaled Carbon Monoxide

Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01818843
Acronym
CO
Enrollment
24
Registered
2013-03-27
Start date
2012-04-30
Completion date
2013-12-31
Last updated
2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscellaneous Disorders in the Fetus or Newborn

Keywords

Carbon monoxide, safety, Adverse Reaction, newborn

Brief 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

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

Interventions

Inhaled Carbon Monoxide in newborn

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
CollaboratorOTHER
CAN WANG
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 1 Months
Healthy volunteers
Yes

Inclusion criteria

* The newborn whose physiological function is healthy or close to healthy

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Number of participants with adverse eventsup to 1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026