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NCT Number: NCT06557915

Nasal Problems in Neonates and Infants Subjected to CPAP

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

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Key information

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Sohag University

Sohag, 82511, Egypt

Location contact

Ahmed Abdelaal

CONTACT

[email protected]

About this study

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:

  • Full medical history: Name, age, sex, date of birth
  • Indications and duration of CPAP
  • Complete Ear,nose and throat (ENT) examination including endoscopic examination

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

screening

Procedure

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abdelaal

CONTACT

[email protected]

+201064286563

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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