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The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:
I. Primary outcomes:
II. Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Nasal high-frequency ventilation (NHFV) group (case group): |
|
| Group II | Placebo Comparator | Nasal CPAP group (control group): |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHFOV | Device | The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Superior vena cava blood flow in ml/kg/min | The SVC diameter will be visualized from a high parasternal long axis view. The maximum and minimum internal diameters will be then measured. ✓ The SVC flow velocity will be visualized from a low subcostal view and the pulsed Doppler recording will be made at the junction of the SVC and the right atrium. ✓ SVC flow will be calculated using the method described by Kluckow and Evans:(27) SVC flow (ml/kg/min) = [VTI (cm/beat) × 3.14 × (mean SVC diameter2 /4) × heart rate (beat/min)] Body weight in kg 11 | first 3 days of life |
| Right ventricular output in ml /kg/min | CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid- systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR. | first 3 days of life |
| left ventricular output in ml/kg/min | CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius) 2 . ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5- chamber view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR | first 3 days of life |
| peak systolic velocity in anterior cerebral artery in cm/sec | Trans-frontellar cranial sonography using Doppler study | first 3 days of life |
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Inclusion Criteria:
Moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to WHO definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nader Abdelminem Fasseh | Faculty of medicine, Alexandria University, Egypt | Study Director |
| Mohamed Amen Hassan, MBChB | Faculty of medicine, Alexandria University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital. | Alexandria | 0356 | Egypt |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| NCPAP | Device | The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support. |
|
| D007235 |
| Infant, Premature, Diseases |
| 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 |