NCT07041658

Brief Summary

The goal of this observational study is to evaluate nutritional status of critically ill patients admitted to Pediatric Intensive Care Units (PICU) at Sohag University Hospital and its correlation with their outcome as regarding to need for mechanical ventilation, acquired infection, metabolic complications, and mortality.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

May 23, 2025

Last Update Submit

June 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • need for mechanical ventilation

    one week following PICU admission

  • acquired infection

    one week following PICU admission

  • mortality

    one week following PICU admission

Eligibility Criteria

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

critically ill children who admitted in PICUs at Sohag University Hospital

You may qualify if:

  • All critically ill children who admitted in PICUs at Sohag University Hospital with age range from 1 month up to 16 years old.

You may not qualify if:

  • Patient with recurrent admissions to the PICU during the specified study period, only the first admission will be included.
  • Patient with PICU stay less than 48 hours.
  • Patients referred with nutritional regimen or metabolic disease e.g. patients on ketogenic diet and patients with inborn errors of metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Klara Boles Anwer, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Specialist

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 27, 2025

Study Start

June 1, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

June 27, 2025

Record last verified: 2025-06