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

Miscellaneous Disorders in the Fetus or Newborn Clinical Trial

— CO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01818843
• Other study ID #: DapingH 021
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 26, 2013
• Last updated: March 26, 2013
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Miscellaneous Disorders in the Fetus or Newborn

Intervention

Other:
• Inhaled Carbon Monoxide
Inhaled Carbon Monoxide in newborn

Locations

Country	Name	City	State
China	Daping Hospital	ChongQing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
CAN WANG	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		up to 1 month	Yes