NCT07884838

Brief Summary

This prospective cohort study aims to assess enteral feeding practices and the adequacy of energy and protein delivery among mechanically ventilated children admitted to the pediatric intensive care unit.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Oct 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

October 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 26, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2028

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 14, 2026

Last Update Submit

October 14, 2026

Conditions

Critical IllnessMechanical Ventilation Complication

Keywords

Enteral nutritionNutritional adequacyPediatric intensive careMechanical ventilationAssiut

Outcome Measures

Primary Outcomes (1)

  • Number of children achieving adequate energy delivery

    Number of mechanically ventilated children who achieve predefined adequate energy delivery during the assessment period.

    At 7 days

Secondary Outcomes (4)

  • Energy adequacy percentage

    At 7 days

  • Time to initiation of enteral feeding

    At 7 days

  • Duration of mechanical ventilation

    At 28 days

  • PICU length of stay

    At 28 days

Study Arms (1)

Mechanically Ventilated Children

Children aged 1 month to 18 years requiring invasive mechanical ventilation in the PICU who will be followed for enteral feeding practices and nutritional adequacy.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mechanically ventilated children aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit of Assiut University Children's Hospital.

You may qualify if:

  • \- Children aged 1 month to 18 years
  • Admission to the PICU
  • Requirement for invasive mechanical ventilation
  • Expected PICU stay sufficient for assessment of nutritional delivery
  • Written informed consent from parent or legal guardian

You may not qualify if:

  • \- Neonates under 1 month of age
  • Absolute contraindication to enteral feeding
  • Exclusive parenteral nutrition from admission
  • Death or transfer within 48 hours of admission
  • Inborn errors of metabolism needing special diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ismail L Mohammed, prof

    Pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Marina H Marzouk, Resident

CONTACT

+20 12 11834760marinahelal33@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Pediatrics

Study Record Dates

First Submitted

October 14, 2026

First Posted

October 21, 2026

Study Start (Estimated)

October 26, 2026

Primary Completion (Estimated)

October 26, 2027

Study Completion (Estimated)

February 10, 2028

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share