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

March 26, 2013 updated by: CAN WANG

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • ChongQing, Chongqing, China, 400042
        • Daping Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: up to 1 month
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAN WANG

Collaborators

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

March 23, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DapingH 021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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