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A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)
The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown.
Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP.
The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure.
This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP.
The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| noninvasive high frequency oscillatory ventilation (NHFOV) | Experimental | After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support |
|
| noninvasive positive pressure ventilation (NIPPV) | Active Comparator | After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| noninvasive high frequency oscillatory ventilation | Device | A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-intubation rate | Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Days on the assigned non-invasive respiratory support | To document number of days on the assigned non-invasive respiratory support | 8 weeks or till patient discharge which comes first |
| Days on supplemental oxygen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sondos Ahmed | Contact | 0109440704 | 202 | sondosahmedsalah@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Units (NICUs), Ain Shams University | Recruiting | Cairo | Abbasia | 11517 | Egypt |
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|
| noninvasive positive pressure ventilation | Device | NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on:
|
|
To document number of days on supplemental oxygen
| 8 weeks or till patient discharge which comes first |
| Duration of admission | To document total number of days of admission | 8 weeks or till patient discharge which comes first |
| Mortality rate | To document incidence of mortality during hospitalization | 8 weeks or till patient death which comes first |
| Lung ultrasound score | lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration. | Before extubation and after 2 hours on assigned mode |
| Co2 change | Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after. | Before extubation and after 2 hours on assigned mode |
| Oxygen requirement | Fraction of inspired oxygen required to patients on assigned mode | Before extubation and after 2 hours on assigned mode |
| Incidence of feeding intolerance | Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first |
| Days to reach full intake | Number of days needed by each patient to reach full intake | 8 weeks or till patient discharge which comes first |
| Intracranial hemorrhage | Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first |
| Pneumothorax | Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first |
| Incidence of occurrence of Nasal trauma | Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first |
| incidence of bronchopulmonary dysplasia | Need for supplemental oxygen for at least 28 days, percentage of these patients on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient discharge which comes first |
| Severity of respiratory distress | Assessment of work of breathing on assigned mode by Downe 's score. Score ranges from 0 till 10 . Higher score indicates worse work of breathing. | Before extubation and and after 2 hours on assigned mode |
| Need for Postnatal Steroids | Percentage of patients who needed postnatal steroids administration | 8 weeks or till patient discharge which comes first |
| Chest x ray change | Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree. | Before extubation and and after 2 hours on assigned mode |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D004194 | Disease |
| D012140 | Respiratory Tract Diseases |
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
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