Status:

COMPLETED

Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

Lead Sponsor:

Boston Children's Hospital

Conditions:

Healthy

Eligibility:

All Genders

18-35 years

Phase:

PHASE1

Brief Summary

Hydrogen gas may decrease the degree or incidence of brain injury following ischemia. The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposure...

Detailed Description

Inhaled hydrogen gas (H2) has been shown to have significant protective effects on ischemic organs. Clinical trials abroad have shown promise that treatment of patients suffering from stroke, cardiac ...

Eligibility Criteria

Inclusion

  • Age 18 to 35
  • Able to remain inpatient for duration of admission (24-72 hours)

Exclusion

  • History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;
  • Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;
  • Heritable disorders, such as trisomy 21, cystic fibrosis;
  • Mitochondrial disorders;
  • Currently smoking cigarettes or have a history of smoking cigarettes;
  • The regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment;
  • Any lifetime inpatient hospitalization for respiratory illness;
  • Pregnancy.

Key Trial Info

Start Date :

October 26 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2021

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04046211

Start Date

October 26 2020

End Date

May 1 2021

Last Update

May 6 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115