CClinicalTrials.gg
Not yet recruitingNCT06557915Updated Aug 16, 2024

Nasal Problems in Neonates and Infants Subjected to CPAP

An observational study in Continuous Positive Airway Pressure, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Day to 1 Year. Per ClinicalTrials.gov, last updated 2024-08-16.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
1 Day to 1 Year
Sex
All
01

Study 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 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:

  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
02

Conditions studied

  • Continuous Positive Airway Pressure

Keywords

  • neonates
  • CPAP
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All neonates (full and preterm), infants (less than 1 year) subjected to CPAP with different indications

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Failure to obtain consent.
  • Children above 1 year
  • Adults
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Procedure: screening

Interventions

  • Procedurescreening

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 week following using CPAP in neonates and infants

07

Study locations

1 site
  • Faculty of Medicine, Sohag University
    Sohag, 82511, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06557915
Lead sponsor
Sohag University
Responsible party
Ahmed Mohamed Abdelaal (Evaluation of nasal problems in neonates and infants subjected to CPAP in Sohag University hospitals, Sohag University) — Principal investigator
First posted
Aug 16, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 16, 2024

Study contacts

Ahmed Abdelaal
Contact
ahmedkr80@yahoo.com
+201064286563
Ahmed Abdelaal
principal investigator · faculty of medicine,sohag university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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