Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Study Overview
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Brief Summary
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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
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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).

Official Title
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Normal Saline Nebulization in Prevention of Extubation Failure in Neonates

Conditions
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Neonatal Respiratory Failure

Intervention / Treatment
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* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation. Exclusion Criteria: Neurological, cardiac, surgical or metabolic problems affecting their respiration. Upper obstructive air way disease that might affect the success of extubation.

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: using nebulization<br>extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation , | Drug: Normal saline<br>* Using normal saline nebulization in neonates postextubation<br>|
| No Intervention: No nebulization<br>the other group will only receive the standard only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation by 72 hours post-extubation | Number of participants with successful extubation | within 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung ultrasound score | Number of participants with higher score may have worse prognosis | 72 hours |