Nasal Problems in Neonates and Infants Subjected to CPAP

NCT ID: NCT06557915

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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:

1. Full medical history: Name, age, sex, date of birth
2. Indications and duration of CPAP
3. Complete Ear,nose and throat (ENT) examination including endoscopic examination

Conditions

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Continuous Positive Airway Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

screening

Intervention Type PROCEDURE

screening and detection of nasal problems in Neonates and Infants Subjected to CPAP

Interventions

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screening

screening and detection of nasal problems in Neonates and Infants Subjected to CPAP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Neonates and infants subjected to CPAP and presented to ENT department for assessment of nasal condition

Exclusion Criteria

* Failure to obtain consent.
* Children above 1 year
* Adults
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abdelaal

Evaluation of nasal problems in neonates and infants subjected to CPAP in Sohag University hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Abdelaal

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine,sohag university

Locations

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Faculty of Medicine, Sohag University

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Abdelaal

Role: CONTACT

+201064286563

Facility Contacts

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Ahmed Abdelaal

Role: primary

Other Identifiers

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Soh-Med-24-07-05MS

Identifier Type: -

Identifier Source: org_study_id

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