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Ventilator Pressure and Optimization of Compliance and Hemodynamics

NCT06512935 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

Increase in the PEEP followed by decrease in the PEEP

Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics

OTHER

Decrease in the PEEP followed by increase in the PEEP

Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Kulsajan S Bhatia, MD · University of Alabama at Birmingham

  • Colm P Travers, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
7 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-05-01
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06512935 on ClinicalTrials.gov