Using electrical impedance tomography to find the best breathing support for newborns
Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
University Children's Hospital Basel · NCT05612256
This study is testing the best way to help newborns breathe better by using special technology to find the right level of breathing support they need.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | University Children's Hospital Basel (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT05612256 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the optimal level of positive end-expiratory pressure (PEEP) for newborn infants requiring respiratory support. By utilizing electrical impedance tomography (EIT), forced oscillation technique (FOT), and saturation oxygenation pressure index (SOPI), the study seeks to provide a non-invasive assessment of lung ventilation and mechanics. The goal is to minimize ventilator-induced lung injury and improve long-term respiratory outcomes for these infants. The study will be conducted at the University Children's Hospital Basel, focusing on infants with specific gestational ages and mechanical ventilation needs.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants between 22 and 41 weeks of gestational age who require mechanical ventilation.
Not a fit: Patients with major congenital malformations or those on high-frequency oscillatory ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory support strategies for newborns, reducing the risk of lung injury and enhancing recovery.
How similar studies have performed: While the use of EIT and similar techniques in this context is promising, this specific approach to optimizing PEEP in newborns is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 22+0 to 41+6 weeks' gestational age * Requiring mechanical ventilation * Written informed parental consent Exclusion Criteria: * Major congenital malformations including lung and cardiac malformations * Infants on high frequency oscillatory ventilation * Lack of written informed parental consent
Where this trial is running
Basel
- Department of Neonatology, University Children's Hospital Basel UKBB — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Roland Gerull, Dr. med. — Department of Neonatology, University Children's Hospital Basel UKBB
- Study coordinator: Roland Gerull, Dr. med.
- Email: Roland.Gerull@ukbb.ch
- Phone: +41 61 70 42 307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Positive End-expiratory Pressure, respiratory support, newborn infants, ventilator induced lung injury, mechanical ventilation, electrical impedance tomography, forced oscillation technique, saturation oxygenation pressure index