Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Alexandria University

Status: Completed

Conditions: Hemodynamic Instability; Ventilator Lung; Newborn; Echocardiography

Treatments: Device: NHFOV; Device: NCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT05706428

0201417

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 1 hour to 3 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Group I

Active Comparator group

Description:

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

Treatment:

Device: NHFOV

Group II

Placebo Comparator group

Description:

Nasal CPAP group (control group):

Treatment:

Device: NCPAP