Ventilator Pressure and Optimization of Compliance and Hemodynamics (NCT06512935) | Clinical Trial Compass
RecruitingNot Applicable
Ventilator Pressure and Optimization of Compliance and Hemodynamics
United States24 participantsStarted 2026-08-01
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 range
7 Days – 30 Days
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
PEEP of best compliance and best oxygenation as per EIT measurements
Timeframe: During a 4 hour cross-over period on either intervention