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Ventilator Pressure and Optimization of Compliance and Hemodynamics

RecruitingNAAges 7 Days - 30 DaysAllUniversity of Alabama at Birmingham
NCT06512935 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Increase in the PEEP followed by decrease in the PEEP
  • Decrease in the PEEP followed by increase in the PEEP
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Where

1 site
Univerisity of Alabama
Birmingham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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