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

CAN WANG

Status: Unknown

Conditions: Miscellaneous Disorders in the Fetus or Newborn

Treatments: Other: Inhaled Carbon Monoxide

Study type: Interventional

Funder types: Other

Identifiers

NCT01818843

DapingH 021

Details and patient eligibility

About

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

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 1 minute to 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Safety and Adverse Reaction in CO

Experimental group

Description:

Inhaled Carbon Monoxide

Treatment:

Other: Inhaled Carbon Monoxide