NCT01818843

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 28, 2013

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

February 26, 2013

Last Update Submit

March 26, 2013

Conditions

Miscellaneous Disorders in the Fetus or Newborn

Keywords

Carbon monoxidesafetyAdverse Reactionnewborn

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    up to 1 month

Study Arms (1)

Safety and Adverse Reaction in CO

EXPERIMENTAL

Inhaled Carbon Monoxide

Other: Inhaled Carbon Monoxide

Interventions

Inhaled Carbon MonoxideOTHER

Inhaled Carbon Monoxide in newborn

Safety and Adverse Reaction in CO

Eligibility Criteria

Age1 Minute - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The newborn whose physiological function is healthy or close to healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phase 1 Study of Inhaled carbon monoxide on the effectiveness of neonatal pulmonary hypertension

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 27, 2013

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

December 1, 2013

Last Updated

March 28, 2013

Record last verified: 2012-04

Locations

CN(1)