Neonatal Respiratory FailureNCT05194761
Normal Saline Nebulization on Prevention of Extubation Failure in Neonates
A study testing Normal saline in people with Neonatal Respiratory Failure, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.
Who cannot join
- Neurological, cardiac, surgical or metabolic problems affecting their respiration.
- Upper obstructive air way disease that might affect the success of extubation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams University Hospitals
Cairo, 11566
Olivia Saroufim, MSC, 01225801384, oliviazakariasalama@gmail.com
Ghada Saleh, MD, 01148777714, GhadaSaleh@med.asu.edu.eg
About this study
Official title: 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
Read the 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
- Being tested
- Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Using normal saline nebulization in neonates postextubation
| Study group | Role | What they receive |
|---|---|---|
| using nebulization | Active comparator | extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation , Receives: Drug: Normal saline |
| No nebulization | No intervention | the other group will only receive the standard only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation by 72 hours post-extubation
Number of participants with successful extubation
Measured: within 72 hours
Secondary outcomes (1)
Lung ultrasound score
Number of participants with higher score may have worse prognosis
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start3 Oct 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia Zakaria ,MSC, Ain Shams University
- Investigators
- Rania ElFarrash, Prof., Study chair, Ain Shams UniversityIbrahim Abuseif, Prof., Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194761
- Sponsor's protocol ID
- AinShamsUPed
- Status last verified
- Nov 2021
- First submitted
- 31 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Nebulization in Prevention of Extubation Failure in Neonates
- ClinicalTrials.gov ID
- NCT05194761
- Acronym / sponsor ID
- AinShamsUPed
- Conditions
- Neonatal Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| using nebulization | Active comparator | Drug: Normal salineextubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation , |
| No nebulization | No intervention | –the other group will only receive the standard only |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.
Key exclusion criteria (2 listed)
- Neurological, cardiac, surgical or metabolic problems affecting their respiration.
- Upper obstructive air way disease that might affect the success of extubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineUsing normal saline nebulization in neonates postextubation | Drug | using nebulization |
Primary outcome
Reintubation by 72 hours post-extubation
Time frame: within 72 hours
Number of participants with successful extubation
1 secondary outcome
Lung ultrasound score
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania ElFarrash, Prof. study chair
Ain Shams University
Ibrahim Abuseif, Prof. study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline in people with Neonatal Respiratory Failure, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivia Zakaria, MSC (01225801484, oliviazakariasalama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation by 72 hours post-extubation (time frame: within 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.