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Testing Breathing Machine Pressure Settings in Premature Newborns

Tests changes in breathing machine pressure in premature babies on ventilators.

Plain-language title generated from the registry record
Registry title: Ventilator Pressure and Optimization of Compliance and Hemodynamics

Key facts

Where
Birmingham, United StatesSee the site

Where in United States

  • Univerisity of AlabamaBirmingham, United StatesTaking people

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Trial details

Who runs it
University of Alabama at Birmingham
Trial code
NCT06512935
Record updated
26 October 2026
Original description
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.Read full original descriptionShow less

Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial

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.

Inclusion: 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: Cyanotic or ductal-dependent congenital heart disease; Newborns on pressors or steroids for maintaining cardiac output; Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN); Blood culture-positive sepsis; Congenital anomalies affecting respiration; Newborns who are considered too unstable for study enrolment per neonatology attending; Open skin wounds or abrasions on the chest wall.

ClinicalTrials.gov NCT06512935