Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorMedical University of Graz
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No decision to conduct full life support
no written informed consent
gestational age <30+0 weeks of gestation
age > 6 hours
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 4 trial groupsGroup A: Preterm neonates with infection
Group B: Preterm neonates without infection
Group C: Term neonates with infection
Group D: Term neonates without infection
Trial outcomes
Primary outcomes
1
pFTOE
pFTOE within 6 hours after birth
Time frame
5 minutes (duration of 5 re-applications)Secondary outcomes
1
cFTOE
cFTOE and cFTOE/pFTOE within 6 hours after birth
Time frame
5 minutes (duration of 5 re-applications)2
gestational age
term and preterm neonates
Time frame
up to 10 weeks (until term age - discharge)Other outcomes
1
TOI
cTOI, pTOI
Time frame
5 minutes (duration of 5 re-applications)2
routine monitoring data - arterial oxygen saturation (SpO2)
SpO2 in percentage (%)
Time frame
up to 10 weeks (until term age - discharge)3
routine monitoring data - heart rate (HR)
HR im beats per minute (bpm)
Time frame
up to 10 weeks (until term age - discharge)4
routine monitoring data - blood pressure (RR)
RR in mmHg
Time frame
up to 10 weeks (until term age - discharge)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov