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Vasodilator

Inhaled Nitric Oxide for Pulmonary Conditions in Preterm Infants

Phase 1 & 2

Recruiting

Led By Hussnain Mirza, MD

Research Sponsored by AdventHealth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Early pulmonary hypertension

Birth between 23 weeks and 0 days and 29 weeks and 6 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks post menstrual age

Awards & highlights

Study Summary

This trial is testing whether inhaled nitric oxide can decrease the incidence of death and bronchopulmonary dysplasia, and improve oxygenation, in extremely preterm infants.

Who is the study for?

This trial is for preterm infants born between 23 and 29 weeks who need positive pressure ventilation at 72-96 hours old and have early pulmonary hypertension. It's not for those who passed away before their first echocardiogram, have chromosomal anomalies or certain heart defects like complex cardiac defect or major congenital anomalies.Check my eligibility

What is being tested?

The study tests if inhaling nitric oxide (iNO) can help extremely preterm infants with early diagnosed pulmonary hypertension by decreasing death rates or bronchopulmonary dysplasia and improving oxygenation within the first few days of treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, inhaled nitric oxide may cause issues such as headache, dizziness, nausea, methemoglobinemia (a blood disorder), and potentially impact bleeding time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with early-stage high blood pressure in the lungs.

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I was born between 23 and 29 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks post menstrual age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks post menstrual age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks post menstrual age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bronchopulmonary (BPD) dysplasia (yes/no)

Death (yes/no)

Secondary outcome measures

Oxygen saturation level percentage

Pulmonary arterial pressure (mmHg)

SF (SpO2/FiO2) ratio

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Treatment group - activeActive Control1 Intervention

inhaled nitric oxide treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.

Group II: Control groupActive Control1 Intervention

Enrolled infants with no evidence of pulmonary hypertension will serve as the control group for incidence of death or bronchopulmonary hypertension

Group III: Treatment group - placeboPlacebo Group1 Intervention

Placebo treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor

107 Previous Clinical Trials

29,441 Total Patients Enrolled

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,090 Total Patients Enrolled

3 Trials studying Bronchopulmonary Dysplasia

539 Patients Enrolled for Bronchopulmonary Dysplasia

Thrasher Research FundOTHER

132 Previous Clinical Trials

94,236 Total Patients Enrolled

3 Trials studying Bronchopulmonary Dysplasia

147 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

Inhaled Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT03576885 — Phase 1 & 2

Bronchopulmonary Dysplasia Research Study Groups: Treatment group - active, Treatment group - placebo, Control group

Bronchopulmonary Dysplasia Clinical Trial 2023: Inhaled Nitric Oxide Highlights & Side Effects. Trial Name: NCT03576885 — Phase 1 & 2

Inhaled Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03576885 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cumulative participant count of this clinical trial?

"Indeed, as per clinicaltrials.gov's records, this trial is actively recruiting patients. It was first published on July 15th 2019 and its information has been recently updated on April 15th 2022. This research requires the enrolment of 138 participants from one medical site."

Answered by AI

Are there still vacancies in this clinical experiment?

"Indeed, the information on clinicaltrials.gov affirms that this medical trial is present recruiting participants. The initial posting was made on July 15th 2019 and has been recently modified as of April 15th 2022. A total of 138 individuals will be recruited across 1 site to partake in the study."

Answered by AI

Has there been any prior research done related to Treatment group - active?

"Currently, 21 clinical trials are underway dedicated to investigating Treatment group - active. Of these, 8 studies have entered Phase 3 of the trial and 97 locations across the globe are participating in their research endeavors. Anchorage, Alaska is particularly invested with many ongoing experiments related to this treatment."

Answered by AI

For whom is participation in this experiment open?

"This research trial is searching for 138 participants with bronchopulmonary dysplasia and a gestational age between 23 to 29 weeks. Those hoping to join the study should meet these criteria."

Answered by AI