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Search / Trial NCT06512935

Ventilator Pressure and Optimization of Compliance and Hemodynamics

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jul 16, 2024

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Respiratory Distress Syndrome Ventilation Mechanics In Newborn Cardiac Hemodynamics Newborn

ClinConnect Summary

This clinical trial is studying how different levels of pressure in a ventilator can help improve breathing and heart function in very premature infants. Specifically, it focuses on babies born before 34 weeks of pregnancy who are receiving help with their breathing. By adjusting a setting called positive end-expiratory pressure (PEEP), the researchers hope to find the best level that increases blood flow and oxygen levels in these infants. They will use special ultrasound imaging to monitor the babies' heart and lung responses during the study.

To be eligible for this trial, infants must be at least 7 days old but less than 1 month, have a gestational age between 21 and 34 weeks, and be receiving specific types of breathing support. Babies with certain health issues, like infections or heart defects, may not be able to participate. During the trial, infants will undergo a series of tests over a 4-hour period where the PEEP levels will be increased and decreased while their heart and lung functions are closely monitored. This study aims to help find better ways to support the breathing of these vulnerable infants.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Patients applied

0 patients applied

Trial Officials

Kulsajan S Bhatia, MD

Principal Investigator

University of Alabama at Birmingham

Colm P Travers, MD

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported