Monitoring lung function during episodes of low oxygen in newborns
Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants
Rutgers, The State University of New Jersey · NCT06535074
This study is testing how different types of low oxygen episodes affect the lung function of very preterm babies to help find better ways to manage these episodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT06535074 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on very preterm infants who experience hypoxemia episodes, aiming to differentiate the mechanisms behind these episodes through continuous lung volume monitoring. Using a non-invasive electrical impedance tomography device, the study will classify hypoxemia episodes into distinct subtypes based on changes in lung volume. By understanding these mechanisms, the study seeks to inform future strategies for mitigating desaturation episodes in this vulnerable population. The research will involve infants born at or before 32 weeks gestational age who have experienced multiple hypoxemia episodes.
Who should consider this trial
Good fit: Ideal candidates for this study are very preterm infants born at or before 32 weeks gestational age who have had four or more hypoxemia episodes in the previous 24 hours.
Not a fit: Patients with major congenital malformations, those receiving invasive mechanical ventilation, or those with severe neurological injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for hypoxemia in premature infants, potentially reducing the incidence of desaturation episodes.
How similar studies have performed: While this approach using electrical impedance tomography is relatively novel, similar studies have shown promise in understanding respiratory issues in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Born at ≤32w GA * Post menstrual age between 30w to 36w * 4 or more episodes of HEs in the previous 24h (Defined as SpO2\<90≥5s) Exclusion Criteria: * Major congenital malformation * Receiving invasive mechanical ventilation * Severe neurological injury * Hemodynamic instability requiring inotropes in last 72h
Where this trial is running
New Brunswick, New Jersey
- Bristol Myers Squibbs Childrens Hospital — New Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Deepak Jain, MD — Rutgers Robert Wood Johnson Medical School Department of Pediatrics
- Study coordinator: Deepak Jain, MD
- Email: dj392@rwjms.rutgers.edu
- Phone: 7322353377
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: Hypoxemia of Newborn, electrical impedance tomography, hypoxemia episodes, lung volume