Optimizing oxygen control for very low birth weight infants
Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study
NA · Czech Technical University in Prague · NCT06207994
This study is testing if a tighter control on oxygen levels helps very low birth weight babies breathe better than a looser control while they receive respiratory support.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 2 Weeks and up |
| Sex | All |
| Sponsor | Czech Technical University in Prague (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT06207994 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if a narrower target range for oxygen saturation (SpO2) in very low birth weight infants receiving respiratory support is more effective than a wider target range. The research utilizes an automated control system for oxygen delivery (A-FiO2) to enhance precision in managing oxygen levels. By comparing different target ranges, the study seeks to identify the optimal settings that balance the risks of hypoxia and hyperoxia in neonatal care. This investigation is particularly relevant as similar studies on the specific A-FiO2 system used in the NICU have not been conducted before.
Who should consider this trial
Good fit: Ideal candidates for this study are very low birth weight infants on respiratory support and oxygen requirements after 2 weeks of age in the NICU.
Not a fit: Patients who are not on respiratory support or those for whom informed consent cannot be obtained will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oxygen management in very low birth weight infants, potentially reducing complications associated with respiratory distress.
How similar studies have performed: While similar studies have shown success with other A-FiO2 systems, this specific approach has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained. Exclusion Criteria: * Informed consent is not obtained * Recording device for automated control of FiO2 is not available
Where this trial is running
Prague
- Motol University Hospital — Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Ekaterina Orlova, MD — Motol University Hospital Prague, Neonatal Unit
- Study coordinator: Jakub Rafl, PhD
- Email: rafl@fbmi.cvut.cz
- Phone: +420728229991
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: Neonatal Respiratory Distress, Very Low Birth Weight Infant, SpO2 Target Range, pulse oximetry, automatic oxygen control