Clinical trial NCT06557915: Nasal Problems in Neonates and Infants Subjected to CPAP
Official title: Evaluation of Nasal Problems in Neonates and Infants Subjected to CPAP in Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Continuous Positive Airway Pressure
Keywords: neonates
CPAP
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All neonates (full and preterm), infants (less than 1 year) subjected to CPAP with different indications

Brief 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

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

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

Primary outcomes:
measure: Detection of different nasal complications of using CPAP in neonates and infants
timeFrame: 1 week following using CPAP in neonates and infants
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
affiliation: faculty of medicine,sohag university
name: Ahmed Abdelaal
role: PRINCIPAL_INVESTIGATOR
References: