Ventilator Pressure and Optimization of Compliance and Hemodynamics

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID: NCT06512935
Run by: University of Alabama at Birmingham
People needed: 24
Starts: 2026-08-01
Expected to finish: 2027-06-30
Last updated by the study team: 2026-05-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Univerisity of Alabama — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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