Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Echocardiography; Ventilator Lung; Newborn
• Intervention / Treatment: Device: NHFOV; Device: NCPAP

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 0356
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 3 days (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Nader Abdelminem Fasseh, Faculty of Medicine, Alexandria University, Egypt; Principal Investigator: Mohamed Amen Hassan, MBChB, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Premature infants; Echocardiography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 0201417

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No