Continuous Positive Airway PressureNCT06557915
Nasal Problems in Neonates and Infants Subjected to CPAP
An observational study of Continuous Positive Airway Pressure, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this study is to Detect and Screen different nasal complications of using CPAP in neonates and infants and reach a consensus about minimizing nasal problems of CPAP in neonates and infants Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Continuous Positive Airway Pressure
- What is being tested?
- screening
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2024to Dec 2025
- Phase
- Observational
- 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: All neonates (full and preterm), infants (less than 1 year) subjected to CPAP with different indications
Who may be able to join
- Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition
Who cannot join
- Failure to obtain consent.
- Children above 1 year
- Adults
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Sohag University
Sohag, 82511
Ahmed Abdelaal, ahmedkr80@yahoo.com
About this study
Official title: Evaluation of Nasal Problems in Neonates and Infants Subjected to CPAP in Sohag University Hospitals
The goal of this study is to Detect and Screen different nasal complications of using CPAP in neonates and infants and reach a consensus about minimizing nasal problems of CPAP in neonates and infants
Read the detailed description
Continuous Positive Airway Pressure (CPAP) is a means of providing respiratory support to neonates with either upper airway obstruction or respiratory failure. Respiratory failure constitutes either failure of ventilation or failure of lung function.
Nasal CPAP can be delivered through various devices, of which a nasal mask and binasal prongs are the most commonly used. However, earlier studies have described the development of Pressure Injuries (PI) on the nasal skin caused by these nCPAP devices
Nasal complications of nasal CPAP vary from external nasal complications such as columellar hyperemia, columellar necrosis to intranasal complications such as intranasal ulceration, granulation, vestibular stenosis and intranasal synechiae
Aims of the Study:
- Detection and Screening of different nasal complications of using CPAP in neonates and infants
- reach a consensus about minimizing nasal problems of CPAP in neonates and infants
Patients and Methods:
- Type of the study: prospective study.
- Place of the study:
- Pediatric department and its units (Neonatal intensive care unit (NICU), Pediatric intensive care unit (PICU), Critical care unit)
- Otorhinolaryngology department In Sohag university hospitals (old and new)
- Study period: One year from date of acceptance of the protocol.
- Patient:
Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition
- Methods:
All cases will be subjected to:
- Full medical history: Name, age, sex, date of birth
- Indications and duration of CPAP
- Complete Ear,nose and throat (ENT) examination including endoscopic examination
- Conditions
- Continuous Positive Airway Pressure
- Being tested
- screening
- Keywords
- neonates, CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screeningProcedure or surgery
screening and detection of nasal problems in Neonates and Infants Subjected to CPAP
| Study group | Role | What they receive |
|---|---|---|
| Neonates and Infants Subjected to CPAP | * Detection and Screening of different nasal complications of using CPAP in neonates and infants
* reach a consensus about minimizing nasal problems of CPAP in neonates and infants Receives: Procedure: screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of different nasal complications of using CPAP in neonates and infants
the metric used is complete ENT examination of neonates and infants subjected to CPAP
Measured: 1 week following using CPAP in neonates and infants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Positive Airway PressureStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelaal, Sohag University
- Investigators
- Ahmed Abdelaal, Principal investigator, faculty of medicine,sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557915
- Sponsor's protocol ID
- Soh-Med-24-07-05MS
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Problems in Neonates and Infants Subjected to CPAP in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06557915
- Acronym / sponsor ID
- Soh-Med-24-07-05MS
- Conditions
- Continuous Positive Airway Pressure
- Keywords
- neonates, CPAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Aug 2024 (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.
The goal of this study is to Detect and Screen different nasal complications of using CPAP in neonates and infants and reach a consensus about minimizing nasal problems of CPAP in neonates and infants
Detailed description
Continuous Positive Airway Pressure (CPAP) is a means of providing respiratory support to neonates with either upper airway obstruction or respiratory failure. Respiratory failure constitutes either failure of ventilation or failure of lung function.
Nasal CPAP can be delivered through various devices, of which a nasal mask and binasal prongs are the most commonly used. However, earlier studies have described the development of Pressure Injuries (PI) on the nasal skin caused by these nCPAP devices
Nasal complications of nasal CPAP vary from external nasal complications such as columellar hyperemia, columellar necrosis to intranasal complications such as intranasal ulceration, granulation, vestibular stenosis and intranasal synechiae
Aims of the Study:
- Detection and Screening of different nasal complications of using CPAP in neonates and infants
- reach a consensus about minimizing nasal problems of CPAP in neonates and infants
Patients and Methods:
- Type of the study: prospective study.
- Place of the study:
- Pediatric department and its units (Neonatal intensive care unit (NICU), Pediatric intensive care unit (PICU), Critical care unit)
- Otorhinolaryngology department In Sohag university hospitals (old and new)
- Study period: One year from date of acceptance of the protocol.
- Patient:
Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition
- Methods:
All cases will be subjected to:
- Full medical history: Name, age, sex, date of birth
- Indications and duration of CPAP
- Complete Ear,nose and throat (ENT) examination including endoscopic examination
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates and Infants Subjected to CPAP | – | Procedure: screening* Detection and Screening of different nasal complications of using CPAP in neonates and infants * reach a consensus about minimizing nasal problems of CPAP in neonates and infants |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All neonates (full and preterm), infants (less than 1 year) subjected to CPAP with different indications
Key inclusion criteria (1 listed)
- Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition
Key exclusion criteria (3 listed)
- Failure to obtain consent.
- Children above 1 year
- Adults
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 |
|---|---|---|
| screeningscreening and detection of nasal problems in Neonates and Infants Subjected to CPAP | Procedure or surgery | Neonates and Infants Subjected to CPAP |
Primary outcome
Detection of different nasal complications of using CPAP in neonates and infants
Time frame: 1 week following using CPAP in neonates and infants
the metric used is complete ENT examination of neonates and infants subjected to CPAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
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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.
Ahmed Abdelaal principal investigator
faculty of medicine,sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Positive Airway Pressure, run by Sohag 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 3 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 16 Aug 2024. 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 Ahmed Abdelaal (+201064286563, ahmedkr80@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of different nasal complications of using CPAP in neonates and infants (time frame: 1 week following using CPAP in neonates and infants). 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 16 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.