Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Normal Saline Nebulization in Prevention of Extubation Failure in Neonates

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

Study Overview

• Status: Recruiting
• Conditions: Neonatal Respiratory Failure
• Intervention / Treatment: Drug: Normal saline

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia Zakaria, MSC; Phone Number: 01225801484; Email: oliviazakariasalama@gmail.com
• Study Contact Backup: Name: Ghada Saleh, MD; Phone Number: 01148777714; Email: GhadaSaleh@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Recruiting
    • Ainshams university hospitals
    • Contact: Ghada Saleh, MD; Phone Number: 01148777714; Email: GhadaSaleh@med.asu.edu.eg
    • Contact: Olivia Saroufim, MSC; Phone Number: 01225801384; Email: oliviazakariasalama@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: using nebulization; extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation ,	Drug: Normal saline; Using normal saline nebulization in neonates postextubation
NO_INTERVENTION: No nebulization; the other group will only receive the standard only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Rania ElFarrash, Prof., Ain shams university; Study Chair: Ibrahim Abuseif, Prof., Ain shams university

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (ACTUAL): January 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: AinShamsUPed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No