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Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

Primary Purpose

Neonatal Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Respiratory Failure

Eligibility Criteria

undefined - 2 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • AinShams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

using nebulization

No nebulization

Arm Description

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

the other group will only receive the standard only

Outcomes

Primary Outcome Measures

Reintubation by 72 hours post-extubation
Number of participants with successful extubation

Secondary Outcome Measures

Lung ultrasound score
Number of participants with higher score may have worse prognosis

Full Information

First Posted
December 31, 2021
Last Updated
January 18, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05194761
Brief Title
Normal Saline Nebulization on Prevention of Extubation Failure in Neonates
Official Title
Normal Saline Nebulization in Prevention of Extubation Failure in Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
using nebulization
Arm Type
Active Comparator
Arm Description
extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation ,
Arm Title
No nebulization
Arm Type
No Intervention
Arm Description
the other group will only receive the standard only
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Using normal saline nebulization in neonates postextubation
Primary Outcome Measure Information:
Title
Reintubation by 72 hours post-extubation
Description
Number of participants with successful extubation
Time Frame
within 72 hours
Secondary Outcome Measure Information:
Title
Lung ultrasound score
Description
Number of participants with higher score may have worse prognosis
Time Frame
72 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Zakaria, MSC
Phone
01225801484
Email
oliviazakariasalama@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada Saleh, MD
Phone
01148777714
Email
ghadasaleh@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania ElFarrash, Prof.
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ibrahim Abuseif, Prof.
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
AinShams University Hospitals
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Saroufim, MSC
Phone
01225801384
Email
oliviazakariasalama@gmail.com
First Name & Middle Initial & Last Name & Degree
Ghada Saleh, MD
Phone
01148777714
Email
GhadaSaleh@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Normal Saline Nebulization on Prevention of Extubation Failure in Neonates

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