Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates

Preterm Birth Clinical Trial

— pFTOE  

Official title:

Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818762
• Other study ID #: pFTOE
• Status: Recruiting
• Start date: February 26, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: Gerhard Pichler, Prof., MD
• Phone: 0043 316 385 80520
• Email: gerhard.pichler[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Neonatal Infection
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
Austria	Department of Pediatrics, Division of Neonatology, Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TOI	cTOI, pTOI	5 minutes (duration of 5 re-applications)
Other	routine monitoring data - arterial oxygen saturation (SpO2)	SpO2 in percentage (%)	up to 10 weeks (until term age - discharge)
Other	routine monitoring data - heart rate (HR)	HR im beats per minute (bpm)	up to 10 weeks (until term age - discharge)
Other	routine monitoring data - blood pressure (RR)	RR in mmHg	up to 10 weeks (until term age - discharge)
Other	routine monitoring data (temperature)	temperature in °C	up to 10 weeks (until term age - discharge)
Other	Laboratory parameter	C reactive protein (mg/l) - routinely sampled	up to 10 weeks (until term age - discharge)
Other	Laboratory parameter	leukocytes (per µl) - routinely sampled	up to 10 weeks (until term age - discharge)
Other	Laboratory parameter	IT-ratio - routinely sampled	up to 10 weeks (until term age - discharge)
Other	Laboratory parameter	blood cultures - routinely sampled	up to 10 weeks (until term age - discharge)
Other	Demographic data of the neonate	gestational age (weeks)	up to 10 weeks (until term age - discharge)
Other	Demographic data of the neonate	birth weight (grams)	up to 10 weeks (until term age - discharge)
Other	Demographic data of the neonate	risk factors	up to 10 weeks (until term age - discharge)
Other	Data of the neonate	diagnosis (descriptive)	up to 10 weeks (until term age - discharge)
Other	Data of the neonate	therapy (descriptive)	up to 10 weeks (until term age - discharge)
Other	Medication	medication in appropriate dosage	up to 10 weeks (until term age - discharge)
Primary	pFTOE	pFTOE within 6 hours after birth	5 minutes (duration of 5 re-applications)
Secondary	cFTOE	cFTOE and cFTOE/pFTOE within 6 hours after birth	5 minutes (duration of 5 re-applications)
Secondary	gestational age	term and preterm neonates	up to 10 weeks (until term age - discharge)