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

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ClinicalTrials.gov Identifier: NCT01818843
Recruitment Status : Unknown
Verified April 2012 by CAN WANG, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : March 27, 2013
Last Update Posted : March 28, 2013
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

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

Condition or disease Intervention/treatment Phase
Miscellaneous Disorders in the Fetus or Newborn Other: Inhaled Carbon Monoxide Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Inhaled Carbon Monoxide on the Effectiveness of Neonatal Pulmonary Hypertension
Study Start Date : April 2012
Actual Primary Completion Date : January 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Safety and Adverse Reaction in CO
Inhaled Carbon Monoxide
Other: Inhaled Carbon Monoxide
Inhaled Carbon Monoxide in newborn




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: up to 1 month ]


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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: April 2012

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

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs