Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure

NCT ID: NCT01891500

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-09-19

Brief Summary

The investigators in this study are concerned about the harmful effects of oxygen exposure in newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an FDA approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm babies greater than 34 weeks gestation. Hypoxic respiratory failure occurs when a patient's lungs cannot get enough oxygen into their bloodstream. This condition is traditionally treated with high concentrations of oxygen and most often requires the patient be placed on a ventilator (breathing machine). The administration of inhaled nitric oxygen directly into the lungs often improves blood oxygen levels and allows caretakers to reduce the amount of oxygen given to the baby. The purpose of this research study is to evaluate if giving the inhaled nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces the amount of cellular injury from oxygen exposure, and decreases the total amount of time a patient requires supplemental oxygen. This study uses an FDA approved drug in a new manner.

Conditions

Persistent Fetal Circulation Syndrome; Hypertension, Pulmonary, of Newborn, Persistent; Persistent Pulmonary Hypertension of Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Early inhaled nitric oxide

Patients randomized to receive iNO at OI 10-15.

Group Type: EXPERIMENTAL

Inhaled nitric oxide

Intervention Type: DRUG

Drug is initiated at 20ppm. Patients randomized to receive iNO at OI 10-15.

Bioinert inhaled gas (nitrogen gas)

Patients randomized to bioinert inhaled gas at OI 10-15.

Group Type: PLACEBO_COMPARATOR

Nitrogen Gas

Intervention Type: DRUG

Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15.

Crossover iNO

Patients who deteriorate (OI \>20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort.

Group Type: ACTIVE_COMPARATOR

Crossover iNO

Intervention Type: DRUG

Patients who deteriorate (OI \>20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort.

Interventions

Inhaled nitric oxide

Drug is initiated at 20ppm. Patients randomized to receive iNO at OI 10-15.

Intervention Type: DRUG

Nitrogen Gas

Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15.

Intervention Type: DRUG

Crossover iNO

Patients who deteriorate (OI \>20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort.

Intervention Type: DRUG

Other Intervention Names

INOmax; bioinert; bioinert; INOmax

Eligibility Criteria

Inclusion Criteria

• Gestational age ≥ 35 weeks gestation
• Age of life ≤ 48 hours
• Diagnosis of hypoxic respiratory failure (HRF) as defined by a post-ductal SaO2 ≤90% in ≥50% oxygen with a PEEP of ≥ 6cm or an oxygenation index (OI) ≥ 10 but ≤ 15 when mean airway pressure and PaO2 are known.
• Mothers (ages 18 - 65) of eligible subjects for additional data collection

Exclusion Criteria

• Gestational age < 35 weeks gestation.
• Post-natal age > 48 hours.
• Previous treatment with 100% oxygen for longer than 4 hours.
• Confirmed congenital diaphragmatic hernia.
• Suspected or confirmed congenital airway or pulmonary anomaly.
• Suspected or confirmed chromosomal anomaly or genetic aberration, with the exception of patients with trisomy 21 who do not have complex congenital heart disease.
• Infants with pneumothorax as the primary cause of their HRF.
• Infants with confirmed complex congenital heart disease.

• Minimum Eligible Age: 30 Minutes
• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catalina Bazacliu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

00089105

Identifier Type: OTHER

Identifier Source: secondary_id

OCR17867

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201400791

Identifier Type: -

Identifier Source: org_study_id