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

NCT ID: NCT05036161

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2023-12-01

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.

Conditions

Predictive Value of Tests

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Predicting treatment failure of Nasal High Flow in newborns

newborns with respiratory distress treated with NHF

Nasal high flow

Intervention Type: OTHER

Newborns with respiratory distress treated with NHF.

Predicting treatment failure of Continuous Positive Airway Pressure in newborns

newborns with respiratory distress treated with CPAP

Continuous Positive Airway Pressure

Intervention Type: OTHER

Newborns with respiratory distress treated with CPAP.

Interventions

Nasal high flow

Newborns with respiratory distress treated with NHF.

Intervention Type: OTHER

Continuous Positive Airway Pressure

Newborns with respiratory distress treated with CPAP.

Intervention Type: OTHER

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

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Erebouni Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pavel Mazmanyan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel Mazmanyan, Prof

Role: PRINCIPAL_INVESTIGATOR

Head of Department of Neonatology YSMU

Locations

Erebouni Medical Centre, NICU

Yerevan, , Armenia

Site Status: RECRUITING

Republican Institute of Reproductive Health, NICU

Yerevan, , Armenia

Site Status: NOT_YET_RECRUITING

Research Center of Maternal and Child Health Protection NICU

Yerevan, , Armenia

Site Status: NOT_YET_RECRUITING

Countries

Armenia

Central Contacts

Pavel Mazmanyan, Prof

Role: CONTACT

pavelart@gmail.com

+374 10 47 23 40

Ella Mirzoyan, MD

Role: CONTACT

ellamirzoyan@gmail.com

Facility Contacts

Pavel Mazmanyan, Prof

Role: primary

pavelart@gmail.com

+37410472340

Serine Meliksetyan, MD, PhD

Role: primary

serinemn@yahoo.com

Anaida Asatryan, MD

Role: primary

asatryanan@yahoo.com

References

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.

Reference Type: BACKGROUND

PMID: 21278432 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27481760 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30576221 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30896967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31635954 (View on PubMed)

Other Identifiers

N 6-2/2, 2020

Identifier Type: -

Identifier Source: org_study_id