Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants

Alexandria University40 enrolled

Overview

The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neonates Respiratory Distress Non- Invasive Ventilation

Interventions

NCPAPDEVICE

Apply nasal continuous positive airway pressure in intubated patients with respiratory distress at time of weaning

NIPPVDEVICE

Apply nasal intermittent positive pressure ventilation in intubated patients with respiratory distress at time of weaning

NHFOVDEVICE

Apply nasal high frequency ventilation in intubated patients with respiratory distress at time of weaning

Eligibility

Sex: ALLMin age: 1 DayMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The gestational age (GA) is between 34 and 41 weeks. * Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD. * Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting) Exclusion Criteria: * Major congenital anomalies. * Major cardiac diseases. * Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia). * Neurologically insulted neonates who are unable to take adequate spontaneous breathing.

Locations (1)

Marwa Mohamed Farag

Alexandria, Egypt

Outcomes

Primary Outcomes

Failure rate

need for reintubation and invasive mechanical ventilation

Time frame: 72 hours after weaning

Secondary Outcomes

duration of non-invasive ventilation

duration of noninvasive ventilation till patients become weaned to free flow oxygen

Time frame: first 72 hours after weaning from mechanical ventillation

Data from ClinicalTrials.gov

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