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

University of Florida

Status and phase: Withdrawn; Phase 4

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

Treatments: Drug: Crossover iNO; Drug: Inhaled nitric oxide; Drug: Nitrogen Gas

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01891500

00089105 (Other Identifier)

OCR17867 (Other Identifier)

IRB201400791

Details and patient eligibility

About

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.

Sex: All

Ages: 30 minutes to 48 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 3 patient groups, including a placebo group

Early inhaled nitric oxide

Experimental group

Description:

Patients randomized to receive iNO at OI 10-15.

Treatment:

Drug: Inhaled nitric oxide

Bioinert inhaled gas (nitrogen gas)

Placebo Comparator group

Description:

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

Treatment:

Drug: Nitrogen Gas

Crossover iNO

Active Comparator group

Description:

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.

Treatment:

Drug: Crossover iNO