Status:
WITHDRAWN
Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Mallinckrodt
Conditions:
Persistent Fetal Circulation Syndrome
Hypertension, Pulmonary, of Newborn, Persistent
Eligibility:
All Genders
30-48 years
Phase:
PHASE4
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01891500
Start Date
May 1 2016
End Date
September 19 2019
Last Update
January 7 2020
Active Locations (1)
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1
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610