The Safety and Adverse Reaction Study of Neonatal to Inha... | NCT01818843

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

NCT01818843

Sponsor

CAN WANG

Status

Unknown status

Last Update Posted

Mar 28, 2013Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Miscellaneous Disorders in the Fetus or Newborn

Interventions

Inhaled Carbon Monoxide

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Dec 2013Estimated

First Submitted Date

Feb 26, 2013

First Submission Date that Met QC Criteria

Mar 23, 2013

First Posted Date

Mar 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2013

Last Update Posted Date

Mar 28, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 UniversitySponsor-Investigator

Lead Sponsor

CAN WANGOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Safety and Adverse Reaction in CO	Experimental	Inhaled Carbon Monoxide	Other: Inhaled Carbon Monoxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled Carbon Monoxide	Other	Inhaled Carbon Monoxide in newborn	Safety and Adverse Reaction in CO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daping Hospital		Chongqing	Chongqing Municipality	400042	China