Clinical trial NCT05036161: ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates
Official title: ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predictive Value of Tests
Keywords: nasal high flow
NHF
CPAP
ROX
neonatal
newborn
respiratory distress
treatment failure
Lead sponsor: Erebouni Medical Center
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2021-09-05
Enrollment: 100
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonates with respiratory distress

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants requiring escalation of treatment
timeFrame: 72 hours
Secondary outcomes:
measure: Number of participants with death
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants with pneumothorax
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants with Necrotizing enterocolitis stage II-III
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants with Intra-ventricular hemorrhage
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants with Bronchopulmonary dysplasia
timeFrame: through study completion, up to 6 months
measure: Number of participants with Cystic Periventricular Leukomalacia
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants with PDA needed surgical treatment
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants with ROP needing laser treatment
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Number of participants requiring blood transfusion
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: total number of days on O2 / noninvasive ventilation
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
measure: Total number days in the hospital
timeFrame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Erebouni Medical Centre, NICU
city: Yerevan
country: Armenia
facility: Republican Institute of Reproductive Health, NICU
city: Yerevan
country: Armenia
facility: Research Center of Maternal and Child Health Protection NICU
Study officials:
affiliation: Head of Department of Neonatology YSMU
name: Pavel Mazmanyan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Roca O, Messika J, Caralt B, Garcia-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.
citation: Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-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.
citation: Tatkov S. Nasal High-Flow Therapy: Role of FiO2 in the ROX Index. Am J Respir Crit Care Med. 2019 Jul 1;200(1):115-116. doi: 10.1164/rccm.201902-0376LE. No abstract available.
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. No abstract available.