Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Not Applicable

• Conditions: Neonatal Respiratory Failure
• Interventions: Drug: Normal saline

• Registration Number: NCT05194761
• Lead Sponsor: Ain Shams University

Brief Summary

this study is about evaluating the effect of using normal saline nebulization in preventing re-intubation in extubated neonates , provided that the cause of intubation is mainly due to respiratory cause

Detailed Description

Using nebulization is of great debate in neonates especially post extubation as neonates have physiological characteristics such as difficult airway maintenance and clearance, smaller airway caliber, compliant chest wall, poor airway stability, and lower functional residual capacity that account for the diminished delivery of inhaled aerosol.

Nebulized normal saline has historically been used as a placebo typically in studies examining bronchodilator medications and sputum expectorants or used as a carrier to medications. Nowadays, normal saline is a method of enhancing mucociliary clearance has become a clinically accepted adjunct to physiotherapy in the treatment of many chronic lung conditions .

the effect of whether or not nebulization really improves the lung condition is evaluated by lung ultrasound ,It is not only useful in predicting failure of non-invasive ventilation and the need for invasive ventilation, but also has a great value in anticipating extubation success In general, patients with lower lung ultrasound scores show a better chance of extubation success. Each lung will be divided into 3 areas (upper anterior, lower anterior, and lateral) and will be examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18).

Study Timeline

• Study Start: 2021-10-03
• Status Verified: 2021-11
• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-18
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-02-01
• Primary Completion: 2022-07
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.

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Exclusion Criteria

• Neurological, cardiac, surgical or metabolic problems affecting their respiration.

Upper obstructive air way disease that might affect the success of extubation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
using nebulization	Normal saline	extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation ,

Primary Outcome Measures

Name	Time	Method
Reintubation by 72 hours post-extubation	within 72 hours	Number of participants with successful extubation

Secondary Outcome Measures

Name	Time	Method
Lung ultrasound score	72 hours	Number of participants with higher score may have worse prognosis

Trial Locations

Locations (1)

AinShams University Hospitals; 🇪🇬 Cairo, Egypt