Recruiting

PEEP Optimization

Sponsor:

University of Alabama at Birmingham

Code:

NCT06512935

Conditions

Bronchopulmonary Dysplasia

Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Extreme Prematurity

Ventilator Lung; Newborn

Ventilation Perfusion Mismatch

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Increase in the PEEP followed by decrease in the PEEP

Decrease in the PEEP followed by increase in the PEEP

Study Details

Brief 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

Study ID

NCT06512935

Start date

Aug 1, 2026

Status verified date

Aug, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cardiac hemodynamics and respiratory status assessment with increasing PEEP

Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - increase followed by decrease in PEEP.

Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT

active comparator: cardiac hemodynamics and respiratory status assessment with decreasing PEEP

Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - decrease followed by increase in PEEP.

Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT

Interventions

Increase in the PEEP followed by decrease in the PEEP

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

Decrease in the PEEP followed by increase in the PEEP

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

Primary outcome measure

  • Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT [ Time Frame: During a 4 hour cross-over period on either intervention ]
  • PEEP of best compliance and best oxygenation as per EIT measurements [ Time Frame: During a 4 hour cross-over period on either intervention ]

Central Contacts and Locations

Central contacts

Kulsajan S Bhatia, MD

9172149882ksbhatia@uabmc.edu

Colm P Travers, MD

cptravers@uabmc.edu

Locations

Univerisity of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 11, 2026

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-11.