ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates
- Conditions
- Predictive Value of Tests
- Interventions
- Other: Nasal high flowOther: Continuous Positive Airway Pressure
- Registration Number
- NCT05036161
- Lead Sponsor
- Erebouni Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Predicting treatment failure of Nasal High Flow in newborns Nasal high flow newborns with respiratory distress treated with NHF Predicting treatment failure of Continuous Positive Airway Pressure in newborns Continuous Positive Airway Pressure newborns with respiratory distress treated with CPAP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 with Intra-ventricular hemorrhage Monitored for the entire stay in hospital, until discharge, up to 6 months Intra ventricular hemorrhage confirmed by head ultrasound
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
Number of participants with PDA needed surgical treatment Monitored for the entire stay in hospital, until discharge, up to 6 months Patent ductus arteriosus
Number of participants requiring blood transfusion Monitored for the entire stay in hospital, until discharge, up to 6 months Blood transfusion
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 death Monitored for the entire stay in hospital, until discharge, up to 6 months Death before discharge from the hospital
Number of participants with pneumothorax Monitored for the entire stay in hospital, until discharge, up to 6 months Pneumothorax determined by chest radiograph
Trial Locations
- Locations (3)
Erebouni Medical Centre, NICU
🇦🇲Yerevan, Armenia
Republican Institute of Reproductive Health, NICU
🇦🇲Yerevan, Armenia
Research Center of Maternal and Child Health Protection NICU
🇦🇲Yerevan, Armenia