RECRUITING

Ventilator Pressure and Optimization of Compliance and Hemodynamics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial

Quick Facts

Study Start:2025-08-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06512935

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.

Ages Eligible for Study:7 Days to 30 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Post-natal age \> 7 days and less than 1 month (outside golden week protocol)
  2. * Gestational age ≥ 21 weeks and ≤ 34 week
  3. * Infants with written informed consent obtained from legal guardian
  1. * Blood culture-positive sepsis
  2. * Congenital anomalies affecting respiration
  3. * Cyanotic or ductal-dependent congenital heart disease
  4. * Newborns who are considered too unstable for study enrolment per neonatology attending
  5. * Newborns on pressors or steroids for maintaining cardiac output
  6. * Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)
  7. * Open skin wounds or abrasions on the chest wall.

Contacts and Locations

Study Contact

Kulsajan S Bhatia, MD
CONTACT
9172149882
ksbhatia@uabmc.edu
Colm P Travers, MD
CONTACT
cptravers@uabmc.edu

Principal Investigator

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

Study Locations (Sites)

Univerisity of Alabama
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Respiratory distress syndrome
  • ventilation mechanics in newborn
  • cardiac hemodynamics newborn

Additional Relevant MeSH Terms

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