ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates

Study Overview
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Brief Summary
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Nasal continuous positive airway pressure (CPAP) and Nasal High Flow (NHF) therapy are two primary therapies for the treatment of respiratory distress in newborns. However, a considerable number of infants, who are initially treated with CPAP and NHF, will develop worsening respiratory failure and eventually require intubation for mechanical ventilation and the administration of surfactant. Infants who fail noninvasive respiratory therapy may suffer the consequences of delayed intubation, surfactant administration and other adverse outcomes. The most challenging decisions in the management of respiratory distress after birth is to decide when to move from a noninvasive respiratory support to invasive mechanical ventilation and give surfactant to decrease pulmonary damage and improve outcomes. There are no clinically adequate predictors of early CPAP failure at the time of admission to the neonatal intensive care unit. Many measurements have been investigated for their ability to predict CPAP failure in infants such as fraction of inspired oxygen (FiO2), partial pressure of oxygen (PaO2), PaO2/FiO2 and the stable micro bubble test as soon as possible after birth. Roca and colleagues first established the ROX index to predict the success of NHF therapy in adults with pneumonia. The ROX index combines three common measurements: FiO2, peripheral oxygen saturation (SpO2) and respiratory rate. Combining the ROX values with the change in the respiratory rate and FiO2 can indicate whether escalation is required. It was proposed that XY plot of the key components of ROX may show the direction of changes in vector form. The investigators hypothesized that the ROX index and ROX vector can be used for predicting the failure of CPAP and NHF in neonates.

Detailed Description
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The objective is to explore the usefulness of ROX index to predict treatment failure of NHF and CPAP therapies in neonates. The primary outcome is treatment failure within 72 h after start of the therapy with NHF or CPAP Treatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of: Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.

Official Title
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ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates

Conditions
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Predictive Value of Tests

Intervention / Treatment
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* Other: Nasal high flow
* Other: Continuous Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: They are admitted to a NICU when <24 h old, AND The decision has been made by the attending clinician, to commence or continue (from stabilization at birth) non-invasive respiratory support (this does not include the provision of supplemental oxygen alone), AND They have not previously been intubated or received surfactant Exclusion criteria: They immediately require intubation and ventilation (determined by attending clinician), OR They already satisfy 'treatment failure' criteria, OR They have a known major congenital anomaly or air leak

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Predicting treatment failure of Nasal High Flow in newborns<br>newborns with respiratory distress treated with NHF | Other: Nasal high flow<br>* Newborns with respiratory distress treated with NHF.<br>|
| Predicting treatment failure of Continuous Positive Airway Pressure in newborns<br>newborns with respiratory distress treated with CPAP | Other: Continuous Positive Airway Pressure<br>* Newborns with respiratory distress treated with CPAP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants requiring escalation of treatment | Treatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of: Sustained increase in oxygen requirement above ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with death | Death before discharge from the hospital | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants with pneumothorax | Pneumothorax determined by chest radiograph | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants with Necrotizing enterocolitis stage II-III | Necrotizing enterocolitis determined by abdominal radiograph | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants with Intra-ventricular hemorrhage | Intra ventricular hemorrhage confirmed by head ultrasound | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants with Bronchopulmonary dysplasia | Bronchopulmonary dysplasia | through study completion, up to 6 months | 
| Number of participants with Cystic Periventricular Leukomalacia | Cystic Periventricular Leukomalacia confirmed by ultrasound | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants with PDA needed surgical treatment | Patent ductus arteriosus | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants with ROP needing laser treatment | Retinopathy of prematurity needing laser treatment | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Number of participants requiring blood transfusion | Blood transfusion | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| total number of days on O2 / noninvasive ventilation | total number of days on O2 / noninvasive ventilation | Monitored for the entire stay in hospital, until discharge, up to 6 months | 
| Total number days in the hospital | Total number days in the hospital | Monitored for the entire stay in hospital, until discharge, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal high flow, NHF, CPAP, ROX, neonatal, newborn, respiratory distress, treatment failure