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NCT05706428
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
Conditions: Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography
Sex: All
Ages: 1 Hour – 3 Days
Phase: NA
Enrollment: 100
Sponsor: Alexandria University
Location: Egypt
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.
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.
Source: ClinicalTrials.gov (NCT05706428). StuddyBuddy aggregates publicly available trial information.