Clinical trial NCT04818762: Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates
Official title: Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Infection
Preterm Birth
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 80
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term and preterm neonates ≥30+0 weeks of gestation with respiratory distress and risk factors for infection admitted to the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section on the first day after birth will be eligible for the study.

Brief summary: 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

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: pFTOE
timeFrame: 5 minutes (duration of 5 re-applications)
Secondary outcomes:
measure: cFTOE
timeFrame: 5 minutes (duration of 5 re-applications)
measure: gestational age
timeFrame: up to 10 weeks (until term age - discharge)
Other outcomes:
measure: TOI
timeFrame: 5 minutes (duration of 5 re-applications)
measure: routine monitoring data - arterial oxygen saturation (SpO2)
timeFrame: up to 10 weeks (until term age - discharge)
measure: routine monitoring data - heart rate (HR)
timeFrame: up to 10 weeks (until term age - discharge)
measure: routine monitoring data - blood pressure (RR)
timeFrame: up to 10 weeks (until term age - discharge)
measure: routine monitoring data (temperature)
timeFrame: up to 10 weeks (until term age - discharge)
measure: Laboratory parameter
timeFrame: up to 10 weeks (until term age - discharge)
measure: Laboratory parameter
timeFrame: up to 10 weeks (until term age - discharge)
measure: Laboratory parameter
timeFrame: up to 10 weeks (until term age - discharge)
measure: Laboratory parameter
timeFrame: up to 10 weeks (until term age - discharge)
measure: Demographic data of the neonate
timeFrame: up to 10 weeks (until term age - discharge)
measure: Demographic data of the neonate
timeFrame: up to 10 weeks (until term age - discharge)
measure: Demographic data of the neonate
timeFrame: up to 10 weeks (until term age - discharge)
measure: Data of the neonate
timeFrame: up to 10 weeks (until term age - discharge)
measure: Data of the neonate
timeFrame: up to 10 weeks (until term age - discharge)
measure: Medication
timeFrame: up to 10 weeks (until term age - discharge)
Locations:
city: Graz
country: Austria
facility: Department of Pediatrics, Division of Neonatology, Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz, Department of Pediatric and Adolescent Medicine, Division of Neonatology
name: Gerhard Pichler, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: