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

Predictive Value of Tests Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036161
• Other study ID #: N 6-2/2, 2020
• Status: Recruiting
• Start date: September 6, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2021
• Source: Erebouni Medical Center
• Contact: Pavel Mazmanyan, Prof
• Phone: +374 10 47 23 40
• Email: pavelart[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Predictive Value of Tests

Intervention

Other:
• Nasal high flow
Newborns with respiratory distress treated with NHF.
• Continuous Positive Airway Pressure
Newborns with respiratory distress treated with CPAP.

Locations

Country	Name	City	State
Armenia	Erebouni Medical Centre, NICU	Yerevan
Armenia	Republican Institute of Reproductive Health, NICU	Yerevan
Armenia	Research Center of Maternal and Child Health Protection NICU	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
Erebouni Medical Center	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Armenia, 

References & Publications (5)

Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Predictors of early nasal CPAP failure and effects of various intubation criteria on the rate of mechanical ventilation in preterm infants of <29 weeks gestational age. Arch Dis Child Fetal Neonatal Ed. 2011 Sep;96(5):F343-7. doi: 10.1136/adc.2010.205898. Epub 2011 Jan 30. — View Citation

Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, García-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC. — View Citation

Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31. — View Citation

Tatkov S. Nasal High-Flow Therapy: Role of Fi(O2) in the ROX Index. Am J Respir Crit Care Med. 2019 Jul 1;200(1):115-116. doi: 10.1164/rccm.201902-0376LE. — View Citation

Tatkov S. ROX vector to complement ROX index during nasal high flow therapy of hypoxemic patients. J Crit Care. 2020 Aug;58:129. doi: 10.1016/j.jcrc.2019.08.012. Epub 2019 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with death	Death before discharge from the hospital	Monitored for the entire stay in hospital, until discharge, up to 6 months
Secondary	Number of participants with pneumothorax	Pneumothorax determined by chest radiograph	Monitored for the entire stay in hospital, until discharge, up to 6 months
Secondary	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
Secondary	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
Secondary	Number of participants with Bronchopulmonary dysplasia	Bronchopulmonary dysplasia	through study completion, up to 6 months
Secondary	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
Secondary	Number of participants with PDA needed surgical treatment	Patent ductus arteriosus	Monitored for the entire stay in hospital, until discharge, up to 6 months
Secondary	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
Secondary	Number of participants requiring blood transfusion	Blood transfusion	Monitored for the entire stay in hospital, until discharge, up to 6 months
Secondary	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
Secondary	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