Ventilator Pressure Optimization for Premature Infants
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Recruiting
N/AInterventional Study
Bronchopulmonary DysplasiaPulmonary Hypertension Due to Lung Diseases and HypoxiaExtreme PrematurityVentilator Lung; NewbornVentilation Perfusion Mismatch
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
7 Days – 30 Days
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for preterm infants who need help with breathing. Participants will have their ventilator settings changed to see how it affects their oxygen levels and heart function.
Are You a Good Fit for This Trial?
You may be able to join if
I was born before 34 weeks of pregnancy
I am recovering from respiratory distress syndrome
I am receiving breathing support through a ventilator
I am older than 7 days but less than 1 month
My gestational age is between 21 and 34 weeks
I have a legal guardian who gives consent for me to participate
You may not be able to join if
I have a serious infection in my blood
I have birth defects affecting my ability to breathe
I have certain types of heart disease that affect my oxygen levels
I am too unstable for the study according to my doctor
I am taking medications to support my heart function
I am on non-invasive breathing support
I have significant lung issues with high blood pressure in my lungs
I have open wounds on my chest
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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 pro…
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.
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