Trial record 6 of 80 for:    carbon monoxide

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Information provided by (Responsible Party):
CAN WANG, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01818843
First received: February 26, 2013
Last updated: March 26, 2013
Last verified: April 2012
  Purpose

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


Condition Intervention
Miscellaneous Disorders in the Fetus or Newborn
Other: Inhaled Carbon Monoxide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety and Adverse Reaction in CO
Inhaled Carbon Monoxide
Other: Inhaled Carbon Monoxide
Inhaled Carbon Monoxide in newborn

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

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818843

Locations
China, Chongqing
Daping Hospital
ChongQing, Chongqing, China, 400042
Sponsors and Collaborators
CAN WANG
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  More Information

No publications provided

Responsible Party: CAN WANG, Phase 1 Study of Inhaled carbon monoxide on the effectiveness of neonatal pulmonary hypertension, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT01818843     History of Changes
Other Study ID Numbers: DapingH 021
Study First Received: February 26, 2013
Last Updated: March 26, 2013
Health Authority: China: Ministry of Health

Keywords provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Carbon monoxide
safety
Adverse Reaction
newborn

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014