Predictive Value of Tests
Conditions
Keywords
nasal high flow, NHF, CPAP, ROX, neonatal, newborn, respiratory distress, treatment failure
Brief summary
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
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: 1. Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%. 2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.
Interventions
OTHERNasal high flow
Newborns with respiratory distress treated with NHF.
OTHERContinuous Positive Airway Pressure
Newborns with respiratory distress treated with CPAP.
Sponsors
Fisher and Paykel Healthcare
Erebouni Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants requiring escalation of treatment | 72 hours | 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: 1. Sustained increase in oxygen requirement above ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%. 2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with pneumothorax | Monitored for the entire stay in hospital, until discharge, up to 6 months | Pneumothorax determined by chest radiograph |
| Number of participants with Necrotizing enterocolitis stage II-III | Monitored for the entire stay in hospital, until discharge, up to 6 months | Necrotizing enterocolitis determined by abdominal radiograph |
| Number of participants with Intra-ventricular hemorrhage | Monitored for the entire stay in hospital, until discharge, up to 6 months | Intra ventricular hemorrhage confirmed by head ultrasound |
| Number of participants with Bronchopulmonary dysplasia | through study completion, up to 6 months | Bronchopulmonary dysplasia |
| Number of participants with Cystic Periventricular Leukomalacia | Monitored for the entire stay in hospital, until discharge, up to 6 months | Cystic Periventricular Leukomalacia confirmed by ultrasound |
| Number of participants with death | Monitored for the entire stay in hospital, until discharge, up to 6 months | Death before discharge from the hospital |
| Number of participants with ROP needing laser treatment | Monitored for the entire stay in hospital, until discharge, up to 6 months | Retinopathy of prematurity needing laser treatment |
| Number of participants requiring blood transfusion | Monitored for the entire stay in hospital, until discharge, up to 6 months | Blood transfusion |
| total number of days on O2 / noninvasive ventilation | Monitored for the entire stay in hospital, until discharge, up to 6 months | total number of days on O2 / noninvasive ventilation |
| Total number days in the hospital | Monitored for the entire stay in hospital, until discharge, up to 6 months | Total number days in the hospital |
| Number of participants with PDA needed surgical treatment | Monitored for the entire stay in hospital, until discharge, up to 6 months | Patent ductus arteriosus |
Countries
Armenia
Contacts
Primary ContactPavel Mazmanyan, Prof
Backup ContactElla Mirzoyan, MD
Outcome results
None listed