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

NCT05036161 | Unknown

• 1 other identifier: N 6-2/2, 2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Predictive Value of Tests

Keywords

nasal high flow; NHF; CPAP; ROX; neonatal; newborn; respiratory distress; treatment failure

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  72 hours

Secondary Outcomes (11)

• Number of participants with death

  Monitored for the entire stay in hospital, until discharge, up to 6 months

• Number of participants with pneumothorax

  Monitored for the entire stay in hospital, until discharge, up to 6 months

• Number of participants with Necrotizing enterocolitis stage II-III

  Monitored for the entire stay in hospital, until discharge, up to 6 months

• Number of participants with Intra-ventricular hemorrhage

  Monitored for the entire stay in hospital, until discharge, up to 6 months

• Number of participants with Bronchopulmonary dysplasia

  through study completion, up to 6 months

Study Arms (2)

Predicting treatment failure of Nasal High Flow in newborns

newborns with respiratory distress treated with NHF

Other: Nasal high flow

Predicting treatment failure of Continuous Positive Airway Pressure in newborns

newborns with respiratory distress treated with CPAP

Other: Continuous Positive Airway Pressure

Interventions

Nasal high flow OTHER

Newborns with respiratory distress treated with NHF.

Predicting treatment failure of Nasal High Flow in newborns

Continuous Positive Airway Pressure OTHER

Newborns with respiratory distress treated with CPAP.

Predicting treatment failure of Continuous Positive Airway Pressure in newborns

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

neonates with respiratory distress

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erebouni Medical Center: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (3)

Erebouni Medical Centre, NICU

Yerevan, Armenia

RECRUITING

Republican Institute of Reproductive Health, NICU

Yerevan, Armenia

NOT YET RECRUITING

Research Center of Maternal and Child Health Protection NICU

Yerevan, Armenia

NOT YET RECRUITING

Related 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.

  PMID: 21278432 BACKGROUND

• 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.

  PMID: 27481760 BACKGROUND

• 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.

  PMID: 30576221 BACKGROUND

• 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.

  PMID: 30896967 BACKGROUND

• 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.

  PMID: 31635954 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Pavel Mazmanyan, Prof

  Head of Department of Neonatology YSMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel Mazmanyan, Prof

CONTACT

+374 10 47 23 40; pavelart@gmail.com

Ella Mirzoyan, MD

CONTACT

ellamirzoyan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 5, 2021
• Study Start: September 6, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (3)