Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Echocardiography; Ventilator Lung; Newborn
• Interventions: Device: NHFOV; Device: NCPAP

• Registration Number: NCT05706428
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-31
• Study Start: 2023-02-01
• Primary Completion: 2023-09-28
• Study Completion: 2023-10-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	NHFOV	Nasal high-frequency ventilation (NHFV) group (case group):
Group II	NCPAP	Nasal CPAP group (control group):

Primary Outcome Measures

Name	Time	Method
Superior vena cava blood flow in ml/kg/min	first 3 days of life	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
Right ventricular output in ml /kg/min	first 3 days of life	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.
left ventricular output in ml/kg/min	first 3 days of life	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
peak systolic velocity in anterior cerebral artery in cm/sec	first 3 days of life	Trans-frontellar cranial sonography using Doppler study

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt