Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, 8036, Austria
Location status: Recruiting
Location contact
Gerhard Pichler, MD
CONTACT
Gerhard Pichler, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04818762
This is a prospective observational pilot study investigating if peripheral fractional tissue oxygen extraction (pFTOE) measured by five short near-infrared spectroscopy (NIRS) (re-)applications within the first 6 hours after birth in neonates with respiratory distress differs in neonates with early onset infection and neonate without infection
Interested in participating?
Request InfoUp to 6 hour
All sexes
Observational
Graz, Styria, 8036, Austria
Location status: Recruiting
Gerhard Pichler, MD
CONTACT
Gerhard Pichler, MD
PRINCIPAL_INVESTIGATOR
Background Near-infrared spectroscopy (NIRS) enables non-invasive, continuous monitoring of oxygenation and perfusion in different tissues. In several studies NIRS has been described to have the potential to detect centralisation due to perfusion heterogeneity, arterio-venous shunting and impaired autoregulation. Thus, peripheral muscle NIRS measurement has the potential to provide information at early stages of inflammation also due to infection, due to microvascular dysfunction, when other routine vital parameters are still within normal ranges.
Objectives
Primary aim To assess, if pFTOE measured by five short NIRS (re-)applications within the first 6 hours after birth differs in neonates with early onset infection and neonates without infection.
Secondary aims To assess, if cerebral fractional tissue oxygen extraction (cFTOE) and cFTOE/pFTOE measured by five short NIRS (re-)applications within the first 6 hours after birth differs in neonates with early onset infection and neonates without infection. To assess, if there is a difference in pFTOE, cFTOE and cFTOE/pFTOE between term and preterm neonates.
Methods
Study population: Term and preterm neonates ≥30+0 weeks of gestation with respiratory distress and risk factors for infection admitted to the neonatal intensive care unit (NICU) on the first day after vaginal delivery or caesarean section on the first day after birth will be eligible for this study. Inclusion criteria are signs of respiratory distress at time-point of inclusion, age <6h and decision to conduct full life support. There will be four groups consisted with term(1) and preterm(2) neonates with early onset infection and term(3) and preterm(4) neonates without.
Procedure: Patients and maternal medical history, routinely sampled laboratory results and blood culture will be documented in each neonate.
Measurement: The NIRS-measurement will take place once within 6 hours after birth. For NIRS measurements the NIRO 200NX will be used and the NIRS sensors will be applied by hand on the right forearm (pTOI) and on the left forehead (cTOI) until stable signals are obtained for approximately 30 seconds, respectively. Then the sensors will be removed for 10sec rest period. After that the sensors will be reapplied in approximately the same positions. This procedure will be repeated five times.
Level of originality As many term and preterm neonates are admitted to the NICU after birth due to respiratory distress, there is growing interest in methods enabling to recognize subtle early signs like micro-vascular dysfunction due to infection. In the present study the investigators want to evaluate in neonates with respiratory distress if peripheral muscle and cerebral FTOE measured by short reapplications with NIRS in the first hours after birth enables to recognize early microvascular dysfunction and compromised oxygenation due to infections.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 minutes (duration of 5 re-applications)
pFTOE within 6 hours after birth
Time frame: 5 minutes (duration of 5 re-applications)
cFTOE and cFTOE/pFTOE within 6 hours after birth
Time frame: up to 10 weeks (until term age - discharge)
term and preterm neonates
Time frame: 5 minutes (duration of 5 re-applications)
cTOI, pTOI
Time frame: up to 10 weeks (until term age - discharge)
SpO2 in percentage (%)
Time frame: up to 10 weeks (until term age - discharge)
HR im beats per minute (bpm)
Time frame: up to 10 weeks (until term age - discharge)
RR in mmHg
Time frame: up to 10 weeks (until term age - discharge)
temperature in °C
Time frame: up to 10 weeks (until term age - discharge)
C reactive protein (mg/l) - routinely sampled
Time frame: up to 10 weeks (until term age - discharge)
leukocytes (per µl) - routinely sampled
Time frame: up to 10 weeks (until term age - discharge)
IT-ratio - routinely sampled
Time frame: up to 10 weeks (until term age - discharge)
blood cultures - routinely sampled
Time frame: up to 10 weeks (until term age - discharge)
gestational age (weeks)
Time frame: up to 10 weeks (until term age - discharge)
birth weight (grams)
Time frame: up to 10 weeks (until term age - discharge)
risk factors
Time frame: up to 10 weeks (until term age - discharge)
diagnosis (descriptive)
Time frame: up to 10 weeks (until term age - discharge)
therapy (descriptive)
Time frame: up to 10 weeks (until term age - discharge)
medication in appropriate dosage
Contact information is provided by the study sponsor or research team.
Christina Wolfsberger, MD
CONTACT
Gerhard Pichler, Prof., MD
CONTACT
Medical University of Graz
Other
Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study
Acronym: pFTOE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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