NCT06368973

Brief Summary

The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

April 11, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

Mechanical Ventilation, Complications,Co-morbidities.

Outcome Measures

Primary Outcomes (1)

  • Adverse events associated with mechanical ventilation

    to assess incidence of complications associated with invasive ventilation in critically ill children

    4 weeks after following usage of invasive mechanical ventilation

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

all pediatric patients aged 29 days to 16 years who were admitted to the PICU and underwent IMV for at least 24 hours between January 2021 and December 2023. Our analysis included data gathered from the follow-up medical records maintained by the PICU team and other healthcare providers.

You may qualify if:

  • all pediatric patients aged 29 days to 16 years who were admitted to the pediatric intensive care unit and underwent invasive mechanical ventilation for at least 24 hours between January 2021 and December 2023.

You may not qualify if:

  • newborns (\<29 days old),
  • pediatric patients received invasive mechanical ventilation less than 24 hours
  • children with chronic respiratory failure or unable to be discharged due to socioeconomic constraints and requiring long-term mechanical ventilation therapy and pediatric patients with incomplete data or transferred to another hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital

Cairo, 13511, Egypt

Location

Study Officials

  • Amany M. El-Rebigi, MD

    Pediatric and Neonatology Department, Benha Faculty of Medicine, Benha University, Benha, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric and Neonatology

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

January 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations