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

NCT ID: NCT01818843

Last Updated: 2013-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Miscellaneous Disorders in the Fetus or Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Safety and Adverse Reaction in CO

Inhaled Carbon Monoxide

Group Type EXPERIMENTAL

Inhaled Carbon Monoxide

Intervention Type OTHER

Inhaled Carbon Monoxide in newborn

Interventions

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Inhaled Carbon Monoxide

Inhaled Carbon Monoxide in newborn

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

CAN WANG

OTHER

Sponsor Role lead

Responsible Party

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CAN WANG

Phase 1 Study of Inhaled carbon monoxide on the effectiveness of neonatal pulmonary hypertension

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Daping Hospital

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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DapingH 021

Identifier Type: -

Identifier Source: org_study_id

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