Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

NCT ID: NCT05194761

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-03
• Study Completion Date: 2022-10-31

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).

Conditions

Neonatal Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

using nebulization

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

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

Using normal saline nebulization in neonates postextubation

No nebulization

the other group will only receive the standard only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Normal saline

Using normal saline nebulization in neonates postextubation

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Olivia Zakaria ,MSC

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania ElFarrash, Prof.

Role: STUDY_CHAIR

Ain Shams University

Ibrahim Abuseif, Prof.

Role: STUDY_CHAIR

Ain Shams University

Locations

AinShams University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Olivia Zakaria, MSC

Role: CONTACT

oliviazakariasalama@gmail.com

01225801484

Ghada Saleh, MD

Role: CONTACT

ghadasaleh@med.asu.edu.eg

01148777714

Facility Contacts

Olivia Saroufim, MSC

Role: primary

oliviazakariasalama@gmail.com

01225801384

Ghada Saleh, MD

Role: backup

GhadaSaleh@med.asu.edu.eg

01148777714

Other Identifiers

AinShamsUPed

Identifier Type: -

Identifier Source: org_study_id