Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557915
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Nasal Problems in Neonates and Infants Subjected to CPAP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Nasal Problems in Neonates and Infants Subjected to CPAP in Sohag University Hospitals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Earnose and throat ENT examination including endoscopic examination
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 Earnose and throat ENT examination including endoscopic examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None