Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

NCT ID: NCT05706428

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-10-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I

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

Group Type: ACTIVE_COMPARATOR

NHFOV

Intervention Type: DEVICE

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

Group II

Nasal CPAP group (control group):

Group Type: PLACEBO_COMPARATOR

NCPAP

Intervention Type: DEVICE

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

Interventions

NHFOV

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

Intervention Type: DEVICE

NCPAP

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Farag

Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nader Abdelminem Fasseh

Role: STUDY_DIRECTOR

Faculty of medicine, Alexandria University, Egypt

Mohamed Amen Hassan, MBChB

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Alexandria University, Egypt

Locations

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

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0201417

Identifier Type: -

Identifier Source: org_study_id