NCT05194761

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 1, 2022

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

December 31, 2021

Last Update Submit

January 18, 2022

Conditions

Neonatal Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Reintubation by 72 hours post-extubation

    Number of participants with successful extubation

    within 72 hours

Secondary Outcomes (1)

  • Lung ultrasound score

    72 hours

Study Arms (2)

using nebulization

ACTIVE COMPARATOR

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

Drug: Normal saline

No nebulization

NO INTERVENTION

the other group will only receive the standard only

Interventions

Normal salineDRUG

Using normal saline nebulization in neonates postextubation

using nebulization

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.

You may not qualify if:

  • Neurological, cardiac, surgical or metabolic problems affecting their respiration.
  • Upper obstructive air way disease that might affect the success of extubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University Hospitals

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Rania ElFarrash, Prof.

    Ain Shams University

    STUDY CHAIR

  • Ibrahim Abuseif, Prof.

    Ain Shams University

    STUDY CHAIR

Central Study Contacts

Olivia Zakaria, MSC

CONTACT

01225801484oliviazakariasalama@gmail.com

Ghada Saleh, MD

CONTACT

01148777714ghadasaleh@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 18, 2022

Study Start

October 3, 2021

Primary Completion

July 1, 2022

Study Completion

October 1, 2022

Last Updated

February 1, 2022

Record last verified: 2021-11

Locations

EG(1)