Adjusting ventilator PEEP to improve lung compliance and heart function in preterm infants

Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial

We will try changing the ventilator's PEEP settings in babies born before 34 weeks who need breathing support to see if the PEEP that gives the best lung compliance improves heart output and oxygen levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 7 Days to 30 Days
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT06512935 on ClinicalTrials.gov

What this trial studies

This randomized crossover protocol enrolls preterm infants under 34 weeks gestation who remain on invasive mechanical ventilation or high-frequency jet ventilation and are recovering from respiratory distress. Infants are randomized to a 4-hour crossover sequence of increasing or decreasing PEEP from baseline with step changes of +1 and +2 cmH2O and a 15-minute washout before measurements. At each PEEP step clinicians will record lung compliance, oxygenation, and cardiac hemodynamics using point-of-care echocardiography and electrical impedance tomography (EIT). The approach tests whether the PEEP that yields best compliance also produces higher cardiac output and better oxygenation.

Who should consider this trial

Good fit: Preterm infants born before 34 weeks, more than 7 days and less than 1 month old, who are receiving invasive mechanical ventilation or HFJV for recovering RDS and whose guardians provide consent.

Not a fit: Infants with blood culture–positive sepsis, major congenital respiratory anomalies, cyanotic or ductal-dependent heart disease, those considered too unstable, on pressors or steroids for cardiac support, on non-invasive ventilation, with significant BPD and pulmonary hypertension, or with open chest wall wounds are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this method could help clinicians choose ventilator PEEP that improves oxygenation and cardiac output while potentially reducing lung injury in preterm infants.

How similar studies have performed: Small physiologic studies have suggested individualized PEEP can improve lung mechanics and oxygenation, but combining point-of-care echocardiography with EIT for simultaneous lung and cardiac optimization in this population is relatively novel.

Eligibility criteria

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 this trial is running

Birmingham, Alabama

• Univerisity of Alabama — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Kulsajan S Bhatia, MD — University of Alabama at Birmingham
• Study coordinator: Kulsajan S Bhatia, MD

Conditions Bronchopulmonary Dysplasia; Pulmonary Hypertension Due to Lung Diseases and Hypoxia; Extreme Prematurity; Ventilator Lung; Newborn; Ventilation Perfusion Mismatch; Respiratory distress syndrome; ventilation mechanics in newborn