Predictive Value of TestsNCT05036161
ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates
An observational study of Predictive Value of Tests, run by Erebouni Medical Center at 3 sites in Armenia.
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… Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Predictive Value of Tests
- What is being tested?
- Nasal high flow and Continuous Positive Airway Pressure
- How many people
- 100 participants
- Where
- 3 sitesArmenia
- Study dates
- 6 Sep 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: neonates with respiratory distress
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Ella Mirzoyan, MD contact
Armenia3 sites, 3 recruiting
- Recruiting
Erebouni Medical Centre, NICU
Yerevan
Pavel Mazmanyan, Prof, +37410472340, pavelart@gmail.com
- Not yet recruiting
Republican Institute of Reproductive Health, NICU
Yerevan
Serine Meliksetyan, MD, PhD, serinemn@yahoo.com
- Not yet recruiting
Research Center of Maternal and Child Health Protection NICU
Yerevan
Anaida Asatryan, MD, asatryanan@yahoo.com
About this study
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.
Read the 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:
- Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%.
- Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.
- Conditions
- Predictive Value of Tests
- Being tested
- Nasal high flow, Continuous Positive Airway Pressure
- Keywords
- nasal high flow, NHF, CPAP, ROX, neonatal, newborn, respiratory distress, treatment failure
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flowOther
Newborns with respiratory distress treated with NHF.
Continuous Positive Airway PressureOther
Newborns with respiratory distress treated with CPAP.
| Study group | Role | What they receive |
|---|---|---|
| Predicting treatment failure of Nasal High Flow in newborns | newborns with respiratory distress treated with NHF Receives: Other: Nasal high flow | |
| Predicting treatment failure of Continuous Positive Airway Pressure in newborns | newborns with respiratory distress treated with CPAP Receives: Other: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (11)
Number of participants with death
Death before discharge from the hospital
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with pneumothorax
Pneumothorax determined by chest radiograph
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with Necrotizing enterocolitis stage II-III
Necrotizing enterocolitis determined by abdominal radiograph
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with Intra-ventricular hemorrhage
Intra ventricular hemorrhage confirmed by head ultrasound
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with Bronchopulmonary dysplasia
Bronchopulmonary dysplasia
Measured: through study completion, up to 6 months
Number of participants with Cystic Periventricular Leukomalacia
Cystic Periventricular Leukomalacia confirmed by ultrasound
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with PDA needed surgical treatment
Patent ductus arteriosus
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with ROP needing laser treatment
Retinopathy of prematurity needing laser treatment
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants requiring blood transfusion
Blood transfusion
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
total number of days on O2 / noninvasive ventilation
total number of days on O2 / noninvasive ventilation
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Total number days in the hospital
Total number days in the hospital
Measured: Monitored for the entire stay in hospital, until discharge, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start6 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Predictive Value of TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erebouni Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Pavel Mazmanyan, Erebouni Medical Center
- Investigators
- Pavel Mazmanyan, Prof, Principal investigator, Head of Department of Neonatology YSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036161
- Sponsor's protocol ID
- N 6-2/2, 2020
- Status last verified
- Sep 2021
- First submitted
- 9 Aug 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21278432Roca 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.
PubMed 27481760Roca 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.
PubMed 30576221Tatkov 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.
PubMed 30896967Tatkov 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.
PubMed 31635954
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates
- ClinicalTrials.gov ID
- NCT05036161
- Acronym / sponsor ID
- N 6-2/2, 2020
- Conditions
- Predictive Value of Tests
- Keywords
- nasal high flow, NHF, CPAP, ROX, neonatal, newborn, respiratory distress, treatment failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erebouni Medical CenterUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%.
- Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predicting treatment failure of Nasal High Flow in newborns | – | Other: Nasal high flownewborns with respiratory distress treated with NHF |
| Predicting treatment failure of Continuous Positive Airway Pressure in newborns | – | Other: Continuous Positive Airway Pressurenewborns with respiratory distress treated with CPAP |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- neonates with respiratory distress
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal high flowNewborns with respiratory distress treated with NHF. | Other | Predicting treatment failure of Nasal High Flow in newborns |
| Continuous Positive Airway PressureNewborns with respiratory distress treated with CPAP. | Other | Predicting treatment failure of Continuous Positive Airway Pressure in newborns |
Primary outcome
Number of participants requiring escalation of treatment
Time frame: 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.
11 secondary outcomes
Number of participants with death
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with pneumothorax
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with Necrotizing enterocolitis stage II-III
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with Intra-ventricular hemorrhage
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with Bronchopulmonary dysplasia
Time frame: through study completion, up to 6 months
Number of participants with Cystic Periventricular Leukomalacia
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with PDA needed surgical treatment
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants with ROP needing laser treatment
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Number of participants requiring blood transfusion
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
total number of days on O2 / noninvasive ventilation
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Total number days in the hospital
Time frame: Monitored for the entire stay in hospital, until discharge, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 21278432Fuchs 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.
- Background: PubMed 27481760Roca 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.
- Background: PubMed 30576221Roca 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.
- Background: PubMed 30896967Tatkov 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.
- Background: PubMed 31635954Tatkov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ella Mirzoyan, MD contact
Pavel Mazmanyan, Prof principal investigator
Head of Department of Neonatology YSMU
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Predictive Value of Tests, run by Erebouni Medical Center at 3 sites in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Mazmanyan, Prof (+374 10 47 23 40, pavelart@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants requiring escalation of treatment (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036161, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.