Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

NCT05706428 | Completed

• 1 other identifier: 0201417
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Lung; Newborn; Hemodynamic Instability; Echocardiography

Keywords

Premature infants; Echocardiography

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

Nasal high-frequency ventilation (NHFV) group (case group):

Device: NHFOV

Group II

PLACEBO COMPARATOR

Nasal CPAP group (control group):

Device: NCPAP

Interventions

NHFOV DEVICE

The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.

Group I

NCPAP DEVICE

The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.

Group II

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 0356, Egypt

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nader Abdelminem Fasseh

  Faculty of medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Mohamed Amen Hassan, MBChB

  Faculty of medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 31, 2023
• Study Start: February 1, 2023
• Primary Completion: September 28, 2023
• Study Completion: October 13, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

EG (1)