Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/2/2019 |
| Start Date: | May 2016 |
| End Date: | October 2019 |
| Contact: | Catalina Bazacliu, MD |
| Email: | cbazacliu@peds.ufl.edu |
| Phone: | 352-273-8985 |
Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure
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.
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.
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.
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