NCT06512935 Ventilator Pressure and Optimization of Compliance and Hemodynamics
| NCT ID | NCT06512935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-10-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Kulsajan S Bhatia, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06512935 clinical trial?
This trial is open to participants of all sexes, aged 7 Days or older, up to 30 Days, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06512935 currently recruiting?
Yes, NCT06512935 is actively recruiting participants. Contact the research team at ksbhatia@uabmc.edu for enrollment information.
Where is the NCT06512935 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06512935 clinical trial?
NCT06512935 is sponsored by University of Alabama at Birmingham. The principal investigator is Kulsajan S Bhatia, MD at University of Alabama at Birmingham. The trial plans to enroll 24 participants.