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RecruitingNCT07383051Updated Mar 27, 2026

A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation

An interventional study of Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen and comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients in High Velocity Nasal Insufflation, Simple Oxygen and Weaning Criteria, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 2 Months to 13 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2025, registered Jan 2026).
  • Started Sep 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Months to 13 Years
Sex
All
01

Study summary

A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome

Read the detailed description

A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.

02

Conditions studied

  • High Velocity Nasal Insufflation
  • Simple Oxygen
  • Weaning Criteria
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
2 Months to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 2 months and 13 years old with minimum weight 4kg
  • Both sexes
  • Patients on mechanical ventilation for at least 24 hours for any indication

Exclusion criteria

Exclusion Criteria:

  • Patients not ready for weaning from mechanical ventilation
  • Contraindications to use of High velocity nasal insufflation
  • Prolonged mechanical ventilation for more than 21 days
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Exubation of pediatric patients on High Velocity Nasal Insufflation

    Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen · Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients

  • Active comparator
    Exubation of pediatric patients on simple oxygen

    Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen · Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients

Interventions

  • DeviceComparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen

    A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.

  • Devicecomparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients

    A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.

06

What researchers measure

Primary outcomes

  1. comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen

    Successful extubation with no need for reintubation within 48 hours among pediatric ICU patients in those using High Velocity Nasal Insufflation versus simple oxygen

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • Cairo University
    Cairo, Cairo Governorate, Egypt
    • Cairo University Cairo University · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared as per the individual signed consent to participate.

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 Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07383051
Lead sponsor
Cairo University
Responsible party
Sherin Tarek Fayez Ali (Cairo University, Cairo University) — Principal investigator
First posted
Feb 3, 2026
Start date
Sep 20, 2025
Primary completion
Sep 20, 2026 (estimated)
Completion
Sep 20, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Sherin T. Fayez Ali, PICU doctor
Contact
tareksherin16@gmail.com
+01153576707
Cairo University Cairo University
principal investigator · Cairo University

Oversight

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

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