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Not yet recruiting NCT06557915

Nasal Problems in Neonates and Infants Subjected to CPAP

Observational Continuous Positive Airway Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: screening.
Who it may be relevant to
Registry conditions: Continuous Positive Airway Pressure. Basic parameters: 1 Day — 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Nasal Problems in Neonates and Infants Subjected to CPAP in Sohag University Hospitals

Overview

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:

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

Interventions

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

Primary outcome measures

  • Detection of different nasal complications of using CPAP in neonates and infants [Time frame: 1 week following using CPAP in neonates and infants]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Egypt · 1 center
  • Faculty of Medicine, Sohag University — Sohag

Identifiers

NCT: NCT06557915 · Soh-Med-24-07-05MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗