Nasal Problems in Neonates and Infants Subjected to CPAP

August 14, 2024 updated by: Ahmed Mohamed Abdelaal, Sohag University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
screening and detection of nasal problems in Neonates and Infants Subjected to CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of different nasal complications of using CPAP in neonates and infants
Time Frame: 1 week following using CPAP in neonates and infants
the metric used is complete ENT examination of neonates and infants subjected to CPAP
1 week following using CPAP in neonates and infants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Ahmed Abdelaal, faculty of medicine,sohag university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med-24-07-05MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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