Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Neonatal Respiratory Failure Clinical Trial

Official title:

Normal Saline Nebulization in Prevention of Extubation Failure in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194761
• Other study ID #: AinShamsUPed
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2021
• Est. completion date: October 2022

Study information

• Verified date: November 2021
• Source: Ain Shams University
• Contact: Olivia Zakaria, MSC
• Phone: 01225801484
• Email: oliviazakariasalama[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Normal saline
Using normal saline nebulization in neonates postextubation

Locations

Country	Name	City	State
Egypt	AinShams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation by 72 hours post-extubation	Number of participants with successful extubation	within 72 hours
Secondary	Lung ultrasound score	Number of participants with higher score may have worse prognosis	72 hours