RecruitingNot Applicable

Ventilator Pressure and Optimization of Compliance and Hemodynamics

United States24 participantsStarted 2025-08-01

Plain-language summary

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 participate

Age range7 Days – 30 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT

Timeframe: During a 4 hour cross-over period on either intervention

PEEP of best compliance and best oxygenation as per EIT measurements

Timeframe: During a 4 hour cross-over period on either intervention

Trial details

NCT IDNCT06512935

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

Contact for this trial

Kulsajan S Bhatia, MD

9172149882 ksbhatia@uabmc.edu