Measuring oxygen extraction in newborns with and without infections
Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study
This study is trying to see if measuring oxygen levels in the blood can show differences between newborns with infections and those without, to help understand their breathing problems better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 6 Hours |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT04818762 on ClinicalTrials.gov |
What this trial studies
This observational pilot study investigates the differences in peripheral fractional tissue oxygen extraction (pFTOE) in term and preterm neonates with respiratory distress, comparing those with early onset infections to those without. Using near-infrared spectroscopy (NIRS), the study aims to monitor oxygenation and perfusion non-invasively within the first six hours after birth. The primary objective is to determine if pFTOE measurements differ between the two groups, while secondary objectives include assessing cerebral fractional tissue oxygen extraction (cFTOE) and the relationship between cFTOE and pFTOE. The study population includes neonates at risk for infection admitted to the neonatal intensive care unit (NICU).
Who should consider this trial
Good fit: Ideal candidates are term and preterm neonates aged less than 6 hours with signs of respiratory distress and risk factors for infection.
Not a fit: Patients who are not undergoing full life support or have severe congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection of infections in newborns, potentially improving treatment outcomes.
How similar studies have performed: While the use of NIRS for monitoring oxygenation is established, this specific application in differentiating infection status in neonates is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signs of respiratory distress at time-point of inclusion (tachypnoea \>60/minutes, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory upport) * Decision to conduct full life support * Written informed consent * Age \< 6 hours Exclusion Criteria: * No decision to conduct full life support * no written informed consent * gestational age \<30+0 weeks of gestation * age \> 6 hours * severe congenital malformations, severe asphyxia (umbilical cord artery pH \<7.00)
Where this trial is running
Graz, Styria
- Department of Pediatrics, Division of Neonatology, Medical University of Graz — Graz, Styria, Austria (Recruiting)
Study contacts
- Principal investigator: Gerhard Pichler, Prof., MD — Medical University of Graz, Department of Pediatric and Adolescent Medicine, Division of Neonatology
- Study coordinator: Gerhard Pichler, Prof., MD
- Email: gerhard.pichler@medunigraz.at
- Phone: 0043 316 385 80520
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.