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Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Normal Saline Nebulization in Prevention of Extubation Failure in Neonates

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05194761
Enrollment
60
Registered
2022-01-18
Start date
2021-10-03
Completion date
2022-10-31
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Respiratory Failure

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).

Interventions

DRUGNormal saline

Using normal saline nebulization in neonates postextubation

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reintubation by 72 hours post-extubationwithin 72 hoursNumber of participants with successful extubation

Secondary

MeasureTime frameDescription
Lung ultrasound score72 hoursNumber of participants with higher score may have worse prognosis

Countries

Egypt

Contacts

Primary ContactOlivia Zakaria, MSC
oliviazakariasalama@gmail.com01225801484
Backup ContactGhada Saleh, MD
ghadasaleh@med.asu.edu.eg01148777714

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026