NCT07764575

Brief Summary

This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Dec 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Extubation FailureNeonatesNICU

Outcome Measures

Primary Outcomes (3)

  • The role of functional echocardiography in predicting exutbation failure

    The role of functional echocardiography in predicting exutbation failure

    baseline

  • The role of Chest ultrasound in predicting extubation failure

    The role of Chest ultrasound in predicting extubation failure

    baseline

  • The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure

    The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure

    baseline

Study Arms (2)

Extubatuin sucess

Parameters of neonates who will be successed to be weaned

Extubation failure

Parameters of neonates who will be failed to be weaned

Eligibility Criteria

Age1 Day+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be carried out in the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital

You may qualify if:

  • Neonates (gestational age 28-44 weeks corrected) mechanically ventilated for ≥48 hours
  • Planned extubation as determined by the treating neonatologist
  • Hemodynamically stable at enrollment

You may not qualify if:

  • Major congenital anomalies
  • Neuromuscular disorders
  • Thoracic malformations
  • Inborn error of metabolism
  • Unplanned/accidental extubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

August 14, 2026

Record last verified: 2026-08