Recruiting

Observational Study

Sponsor:

Sophia Koutsogiannaki

Code:

NCT04296071

Conditions

Lung Injury

Cardiopulmonary Bypass

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Research study

Study Details

Brief summary:

Acute lung injury (ALI) following cardiopulmonary bypass (CPB) is a serious complication, often prolonging the length of stay in ICU and potentially dealing to mortality. The objective of this study is to assess the mechanism of CPB-mediated acute lung injury in pediatric patients.

Conditions

Lung Injury

Cardiopulmonary Bypass

Study ID

NCT04296071

Start date

Oct 14, 2022

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are < 12months of age
  • Scheduled for cardiac surgical needing CPB
  • Preoperative SpO2 > 90%

Exclusion Criteria:

  • Lack of parental (or legal guardian's) consent
  • Preoperative SpO2 < 90%
  • Preoperative oxygen therapy

Study Design

Enrollment

56 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

patients who tend to have longer CPB

Group 2

Patients who have shorter CPB

Interventions

Research study

Blood and tracheal aspirates will be collected

Primary outcome measure

  • Perform neutrophil analysis in blood and tracheal aspirates samples [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sophia Koutsogiannaki, PhD

617-919-4725sophia.koutsogiannaki@childrens.harvard.edu

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Sophia Koutsogiannaki

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sophia Koutsogiannaki on 2026-05-15.