Trial Outcomes & Findings for The Effects of Inhaled Nitric Oxide After Fontan Operation (NCT NCT00945529)

NCT ID: NCT00945529

Last Updated: 2023-05-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 21 participants
• Primary outcome timeframe: until hospital discharge
• Results posted on: 2023-05-19

Participant Flow

Prospective participant recruitment took place between February 2008 and December 2010 at the Nemours Cardiac Center at A. I. duPont hospital for Children.

Participant milestones

Measure	No Intervention/ Historical Control Group historical controls group of patients who did not receive iNO.	Intervention Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Overall Study STARTED	23	21
Overall Study COMPLETED	23	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Inhaled Nitric Oxide After Fontan Operation

Baseline characteristics by cohort

Measure	No Intervention/ Historical Control Group n=23 Participants historical controls group of patients who did not receive iNO / data collected under waiver of consent	Intervention n=21 Participants Prospective group who received iNO / Consent obtained inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.	Total n=44 Participants Total of all reporting groups
Age, Continuous	18.5 months n=5 Participants	21.0 months n=7 Participants	19.7 months n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	21 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: until hospital discharge

Outcome measures

Measure	No Intervention/ Historical Control Group n=23 Participants historical controls group of patients who did not receive iNO.	Intervention n=21 Participants Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Length of Hospital Stay Following Fontan	11.2 days Interval 4.0 to 60.0	11 days Interval 4.5 to 31.0

SECONDARY outcome

Timeframe: 2 weeks

Percent of patients with significant pleural fluid collections that required thoracostomy drainage

Outcome measures

Measure	No Intervention/ Historical Control Group n=23 Participants historical controls group of patients who did not receive iNO.	Intervention n=21 Participants Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage	43.5 percentage	33.4 percentage

Adverse Events

No Intervention/ Historical Control Group

Serious events: 8 serious events

Other events: 7 other events

Deaths: 0 deaths

Intervention

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Intervention/ Historical Control Group n=23 participants at risk Historical controls group of patients who did not receive iNO.	Intervention n=21 participants at risk Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Infections and infestations prolonged hospital stay due to infection	21.7% 5/23 • Number of events 5	9.5% 2/21 • Number of events 2
Metabolism and nutrition disorders Prolonged hospital stay due to feeding issue	0.00% 0/23	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Prolonged hospital stay due to atelectasis	0.00% 0/23	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Prolonged hospital stay due to pleural effusion	17.4% 4/23 • Number of events 4	4.8% 1/21 • Number of events 1
Nervous system disorders Prolonged hospital stay due to seizures	4.3% 1/23 • Number of events 1	0.00% 0/21
Cardiac disorders Prolonged hospital stay due to SVT	4.3% 1/23 • Number of events 1	0.00% 0/21
Surgical and medical procedures Reoperation	0.00% 0/23	4.8% 1/21 • Number of events 1
Infections and infestations Prolonged hospital stay due to sepsis	0.00% 0/23	4.8% 1/21 • Number of events 1

Other adverse events

Measure	No Intervention/ Historical Control Group n=23 participants at risk Historical controls group of patients who did not receive iNO.	Intervention n=21 participants at risk Prospective group who received iNO. inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Respiratory, thoracic and mediastinal disorders Pleural effusion requiring drainage	30.4% 7/23 • Number of events 7	28.6% 6/21 • Number of events 6

Additional Information

Ellen Spurrier, MD

Nemours Cardiac Center at A. I. duPont Hospital for Children

Phone: 302-651-6600

Email: ellen.spurrier@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place