Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support
Neonatal respiratory distress (NRD) is one of the most common problems in the first few days of neonatal life. NRD has been reported to be prevalent in 5 - 29% of the NICU hospitalized neonates.
High-frequency oscillatory ventilation (HFOV) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. It delivers small tidal volumes to improve gas exchange. As it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies HFOV can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia HFOV is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration Several factors are known to influence cerebral perfusion during HFOV. Hypercapnia increases cerebral blood flow (CBF) while a reduction in PaCO2 leads to cerebral vasoconstriction and decreases CBF, Hypoxia is also known to increase CBF via cerebral vasodilation HFOV with volume guarantee (HFOV-VG) is a promising new ventilator mode for the treatment of respiratory failure in newborns. HFOV-VG is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (VThf), reduces the number of out-of-target pCO2 values and provides fewer hypoxia attacks compared with HFOV alone
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG ) | Experimental | After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements |
|
| High Frequency Oscillatory Ventilation (HFOV) | Active Comparator | After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE) | Device | ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P and high-frequency tidal volume (VThf). |
| Measure | Description | Time Frame |
|---|---|---|
| Doppler cerebral blood flow velocity measurements | Investigate the effect of combining the VG mode with HFOV (HFOV-VG), versus the effect of HFOV alone, on Doppler cerebral blood flow velocity measurements | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| efficiency of HFOV-VG in comparison with HFOV alone | Evaluate the efficiency of HFOV-VG in comparison with HFOV alone as a rescue therapy in providing adequate neonatal ventilation and its possible impact on the short-term clinical outcome in terms of mortality and morbidities of these preterm neonates. | 8 weeks or till patient discharged |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Units (NICUs), Ain Shams University | Cairo | Abbasia | 11517 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| High Frequency Oscillatory Ventilation (SLE6000;SLE) | Device | ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P |
|
|
| Duration of admission |
To document total number of days of admission |
| 8 weeks or till patient discharged |
| Mortality rate | To document incidence of mortality during hospitalization | 8 weeks or till patient death which comes first |
| Incidence of feeding intolerance | Percentage of Patients who developed feeding intolerance | 8 weeks or till patient discharged |
| 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 |
| 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 intubation and and after 2 hours on assigned mode |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D012140 | Respiratory Tract Diseases |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided