Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706428
• Other study ID #: 0201417
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: October 13, 2023

Study information

• Verified date: November 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 13, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Echocardiography
• Hemodynamic Instability
• Ventilator Lung; Newborn

Intervention

Device:
• NHFOV
The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.
• NCPAP
The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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) = p 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
Primary	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) = p 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
Primary	peak systolic velocity in anterior cerebral artery in cm/sec	Trans-frontellar cranial sonography using Doppler study	first 3 days of life