Ventilator Pressure and Optimization of Compliance and Hemodynamics
Recruiting · NCT06512935 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
In preterm infants \< 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants. Infants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.
Who can take part
Inclusion criteria
- Preterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \< 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.
- Post-natal age \> 7 days and less than 1 month (outside golden week protocol)
- Gestational age ≥ 21 weeks and ≤ 34 week
- Infants with written informed consent obtained from legal guardian
Exclusion criteria
- Blood culture-positive sepsis
- Congenital anomalies affecting respiration
- Cyanotic or ductal-dependent congenital heart disease
- Newborns who are considered too unstable for study enrolment per neonatology attending
- Newborns on pressors or steroids for maintaining cardiac output
- Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)
- Open skin wounds or abrasions on the chest wall.
Where it is running
1 location listed across 1 US state.
- Univerisity of Alabama - Birmingham, Alabama, United States