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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicting treatment failure of Nasal High Flow in newborns | newborns with respiratory distress treated with NHF |
| |
| Predicting treatment failure of Continuous Positive Airway Pressure in newborns | newborns with respiratory distress treated with CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal high flow | Other | Newborns with respiratory distress treated with NHF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with death | Death before discharge from the hospital | Monitored for the entire stay in hospital, until discharge, up to 6 months |
| Number of participants with pneumothorax |
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Inclusion criteria:
Exclusion criteria:
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neonates with respiratory distress
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavel Mazmanyan, Prof | Contact | +374 10 47 23 40 | pavelart@gmail.com | |
| Ella Mirzoyan, MD | Contact | ellamirzoyan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pavel Mazmanyan, Prof | Head of Department of Neonatology YSMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erebouni Medical Centre, NICU | Recruiting | Yerevan | Armenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21278432 | Background | 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. | |
| 27481760 |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Continuous Positive Airway Pressure | Other | Newborns with respiratory distress treated with CPAP. |
|
Pneumothorax determined by chest radiograph
| 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 | 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 | Monitored for the entire stay in hospital, until discharge, up to 6 months |
| Number of participants with Bronchopulmonary dysplasia | Bronchopulmonary dysplasia | through study completion, up to 6 months |
| 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 |
| Number of participants with PDA needed surgical treatment | Patent ductus arteriosus | 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 | Monitored for the entire stay in hospital, until discharge, up to 6 months |
| Number of participants requiring blood transfusion | Blood transfusion | 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 | 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 | Monitored for the entire stay in hospital, until discharge, up to 6 months |
| Republican Institute of Reproductive Health, NICU | Not yet recruiting | Yerevan | Armenia |
|
| Research Center of Maternal and Child Health Protection NICU | Not yet recruiting | Yerevan | Armenia |
|
| 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. |
| 30576221 | 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. |
| 30896967 | 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. |
| 31635954 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |