Clinical trial NCT01891500: Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure
Official title: Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Persistent Fetal Circulation Syndrome
Hypertension, Pulmonary, of Newborn, Persistent
Persistent Pulmonary Hypertension of Newborn
Keywords: Persistent Fetal Circulation Syndrome
Infant, Newborn
Nitric Oxide
Oxidative Stress
Endothelin 1
Vascular Endothelial Growth Factor
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2013-07-03
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Biomarkers of oxidative injury.
timeFrame: Urine samples will be collected upon enrollment and then at specific time points within the first 48 hours of study intervention to compare the change in biomarker concentrations from baseline up to hour 48.
Secondary outcomes:
measure: Responsiveness to study treatment.
timeFrame: Arterial oxygen concentration will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in arterial oxygen concentration from baseline up to hour 36.
measure: Expression of endothelin-1.
timeFrame: Concentration of endothelin-1 will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentration from baseline up to hour 36.
measure: Markers of inflammation.
timeFrame: Concentrations of pro and anti-inflammatory markers will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentrations from baseline up to hour 36.
measure: Duration of oxygen treatment.
timeFrame: Participants will be followed for the duration of their hospital stay, with an expected average stay of 4 weeks.
measure: Expression of VEGF (vascular endothelial growth factor).
timeFrame: Concentration of VEGF will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentration from baseline up to hour 36.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Catalina Bazacliu, MD
role: PRINCIPAL_INVESTIGATOR
References: