Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Study Overview
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Brief Summary
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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: Duration of the non- invasive respiratory support. Need of invasive ventilation in the first 72 hours. Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma. II. Secondary outcomes: Need for surfactant administration. Days on invasive mechanical ventilation. Days on supplemental oxygen. Duration of hospital stay. Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.

Official Title
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Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress

Conditions
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Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography

Intervention / Treatment
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* Device: NHFOV
* Device: NCPAP


Participation Criteria
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Eligibility Criteria
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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: Any baby intubated for resuscitation or for other reasons. Obvious major congenital malformations or known complex congenital heart disease. Pulmonary hemorrhage. Cardiopulmonary arrest needing prolonged resuscitation.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Nasal high-frequency ventilation (NHFV) group (case group): | Device: NHFOV<br>* The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.<br>|
| Placebo Comparator: Group II<br>Nasal CPAP group (control group): | Device: NCPAP<br>* The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants, Echocardiography