Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth (COSGOD) - a Prospective Two-centre Randomized Controlled Pilot Feasibility Study
Brief Summary: Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth.

Patients: Preterm neonates \<34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study.

Design: A prospective two-centre randomized controlled pilot feasibility study

Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth.

Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 \<10th or \>90th centile in preterm neonates during the first 15 minutes after birth

Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 \<10th or \>90th centile.


Options:
A: Arm Label: cerebral oximetry + treatment guideline; Type: EXPERIMENTAL; Interventions: Device: cerebral oximeter | Intervention Type: DEVICE; Name: cerebral oximeter; Assigned to Arm(s): cerebral oximetry + treatment guideline
B: Arm Label: Surfactant and Low Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: Surfactant and High Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 91 to 95% | Arm Label: CPAP and Low Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: CPAP and High Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 91 to 95% | Intervention Type: DRUG; Name: Surfactant; Assigned to Arm(s): Surfactant and High Oxygen, Surfactant and Low Oxygen | Intervention Type: DEVICE; Name: Continuous Positive Airway Pressure (CPAP); Assigned to Arm(s): CPAP and High Oxygen, CPAP and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 85 to 89%; Assigned to Arm(s): CPAP and Low Oxygen, Surfactant and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 91 to 95%; Assigned to Arm(s): CPAP and High Oxygen, Surfactant and High Oxygen
C: Arm Label: Near Infrared Spectroscopy; Type: EXPERIMENTAL; Interventions: Device: Near Infrared Spectroscopy | Arm Label: Pulse-oximetry; Type: OTHER; Interventions: Device: Pulse-oximetry | Intervention Type: DEVICE; Name: Near Infrared Spectroscopy; Assigned to Arm(s): Near Infrared Spectroscopy | Intervention Type: DEVICE; Name: Pulse-oximetry; Assigned to Arm(s): Pulse-oximetry
D: Arm Label: Cerebral NIRS oximetry + treatment guideline based on reading; Type: EXPERIMENTAL; Interventions: Device: Cerebral NIRS oximetry | Arm Label: Blinded cerebral NIRS oximetry; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Cerebral NIRS oximetry; Assigned to Arm(s): Cerebral NIRS oximetry + treatment guideline based on reading

Answer: C