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Ventilator Pressure for Preterm Infants with Respiratory Issues

This study is looking at how adjusting the pressure from a breathing machine (ventilator) affects very premature babies (born before 34 weeks) who have breathing problems like Bronchopulmonary Dysplasia or Pulmonary Hypertension. Researchers will change the Positive End-Expiratory Pressure (PEEP) on the ventilator, both increasing and decreasing it, to see how these changes affect your baby's heart function (cardiac output) and oxygen levels. They will use special tools called echocardiography (ECHO), which uses sound waves to look at the heart, and electrical impedance tomography (EIT), which measures lung function. The goal is to find the best ventilator settings to help your baby breathe and support their heart. This study plans to include 24 infants.

Study design
This is an interventional study with 24 participants. Infants will be randomly assigned to have their PEEP increased then decreased, or decreased then increased, over a 4-hour period.
What's involved
Your baby would participate in a 4-hour crossover period where ventilator settings are adjusted. Data will be collected using ECHO and EIT measurements after each change.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken during a 4-hour crossover period. No further follow-up is specified after this period.

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NCT06512935

Ventilator Pressure and Optimization of Compliance and Hemodynamics

Recruiting
NAAges 7–30InterventionalTreatment
University of Alabama at Birmingham
~24 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Increase in the PEEP followed by decrease in the PEEPDecrease in the PEEP followed by increase in the PEEP

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT
Measured over During a 4 hour cross-over period on either intervention
+1 more outcome measured

Conditions

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

Explore related trials

Bronchopulmonary DysplasiaExtreme prematurity of infantPulmonary HypertensionRespiratory Distress Syndrome

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Kulsajan S Bhatia, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
  • Colm P Travers, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Kulsajan S Bhatia, MD
[email protected]
9172149882
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EITDuring a 4 hour cross-over period on either intervention
  • PEEP of best compliance and best oxygenation as per EIT measurementsDuring a 4 hour cross-over period on either intervention