RECRUITING

Ventilator Pressure and Optimization of Compliance and Hemodynamics

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. 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.

Study Overview

Study Details

Study overview

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.

Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial

Ventilator Pressure and Optimization of Compliance and Hemodynamics

Condition
Bronchopulmonary Dysplasia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Univerisity of Alabama, Birmingham, Alabama, United States, 35233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

7 Days to 30 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Kulsajan S Bhatia, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Colm P Travers, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2026-06-30