Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Ain Shams University

Status: Unknown

Conditions: Neonatal Respiratory Failure

Treatments: Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05194761

AinShamsUPed

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

using nebulization

Active Comparator group

Description:

extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation ,

Treatment:

Drug: Normal saline

No nebulization

No Intervention group

Description:

the other group will only receive the standard only