NCT06512935 · University of Alabama at Birmingham
Ventilator Pressure and Optimization of Compliance and Hemodynamics
(VPOCH)
What this study 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.
View original scientific description
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.
Interventions
OTHER
Increase in the PEEP followed by decrease in the PEEP
Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics
OTHER
Decrease in the PEEP followed by increase in the PEEP
Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics
Primary outcome measures
Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT
Time frame: During a 4 hour cross-over period on either intervention
PEEP of best compliance and best oxygenation as per EIT measurements
Time frame: During a 4 hour cross-over period on either intervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
Related conditions & keywords
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Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations