Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension
Running, not enrolling · Not applicable
Conditions studied: Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure
In brief
The purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.
Key facts
- Study ID
- NCT04938167
- Run by
- University of California, Davis
- People needed
- 54
- Starts
- 2021-08-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-08
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Corrected gestational age (postmenstrual age) > 34 6/7 weeks
- postnatal age ≤ 28 d
- on respiratory support with invasive mechanical ventilation, non-invasive ventilation, CPAP or high flow nasal cannula (defined as flow rates ≥ 2 LPM with a humidifier), inspired oxygen concentration, FiO2 ≥ 0.3
- and echocardiography shows any finding suggestive of PH (or score > 0 for PH in table 2).
- Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemic encephalopathy (HIE) on therapeutic hypothermia and patent ductus arteriosus (PDA), patent foramen ovale/atrial septal defect (PFO/ASD) and ventricular septal defect (VSD) (single or multiple) < 2 mm can be included in the study.
You may not qualify if…
- < 32 weeks gestation at birth (31 6/7 or lower)
- Weight < 2000 g at the time of enrollment
- Severe HRF with OI > 35 or SpO2 < 75% on FiO2 = 1.0 on mechanical ventilation for > 60 minutes in spite of correction of reversible factors such as pneumothorax
- A condition or congenital anomaly known to be lethal (high likelihood of death during infancy) - e.g., trisomy 18 or trisomy 13
- Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) < 2 mm.
Where it is running
- University of California-Davis — Sacramento, California, United States
Full record on ClinicalTrials.gov
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