Recruiting

Ventilator Pressure and Optimization of Compliance and Hemodynamics

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…

ClinicalTrials.gov IDNCT06512935
PhaseNA
Enrollment24
SponsorUniversity of Alabama at Birmingham
Age7 Days
SexALL
I'm interested View official listing

Conditions studied

Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Extreme Prematurity, Ventilator Lung; Newborn, Ventilation Perfusion Mismatch

About this study

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

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.