NCT07830966

Brief Summary

This prospective cohort study aims to assess the nutritional status of critically ill children aged 1 month to 5 years admitted to the pediatric intensive care unit using a comprehensive ABCD approach including anthropometric, biochemical, clinical, and dietary assessment within 48 hours of admission, and to evaluate its association with clinical outcomes including duration of mechanical ventilation, length of PICU stay, and mortality.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2026

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

Study Progress3%
Sep 2026Jan 2028

First Submitted

Initial submission to the registry

September 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2028

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 15, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

PICUABCDPediatric critical careMechanical ventilationAssiutnutritional assessment

Outcome Measures

Primary Outcomes (1)

  • Nutritional status at PICU admission assessed by ABCD approach

    Number of children classified as malnourished based on comprehensive ABCD assessment including anthropometric measurements body mass index z-score mid-upper arm circumference skinfold thickness, biochemical markers albumin prealbumin total protein, clinical signs of muscle and fat loss, and dietary intake, obtained within 48 hours of PICU admission

    At baseline within 48 hours of admission

Secondary Outcomes (4)

  • Duration of mechanical ventilation

    Up to 30 days

  • Length of PICU stay

    Up to 30 days

  • PICU mortality

    Up to 30 days

  • Feeding intolerance and refeeding syndrome

    Up to 30 days

Study Arms (1)

Critically ill children in PICU

Children aged 1 month to 5 years admitted to PICU with expected stay greater than 48 hours who will undergo comprehensive nutritional assessment using ABCD approach within 48 hours of admission

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Critically ill children aged 1 month to 5 years admitted to PICU at Assiut University Children Hospital

You may qualify if:

  • Age from 1 month to 5 years
  • Admitted to PICU with expected length of stay greater than 48 hours
  • Written informed consent from parents or legal guardians

You may not qualify if:

  • Chronic renal or hepatic disease known to affect serum protein levels
  • Incomplete medical records or discharged or transferred before first laboratory sample could be obtained
  • Receiving nutritional support enteral or parenteral prior to PICU admission for condition unrelated to current critical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.

    PMID: 32077997BACKGROUND
  • Hulst JM, Huysentruyt K, Gerasimidis K, Shamir R, Koletzko B, Chourdakis M, Fewtrell M, Joosten KF; Special Interest Group Clinical Malnutrition of ESPGHAN. A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):693-705. doi: 10.1097/MPG.0000000000003437. Epub 2022 Mar 3.

    PMID: 35258497BACKGROUND
  • Abera EG, Sime H. The prevalence of malnutrition among critically ill children: a systematic review and meta-analysis. BMC Pediatr. 2023 Nov 21;23(1):583. doi: 10.1186/s12887-023-04419-x.

    PMID: 37986053BACKGROUND
  • Agrawal A, Sharma S, Janjua D, Jadon G, Chanchlani R, Dsouza V. Impact of nutritional status on the mortality and clinical outcomes of children admitted to the pediatric intensive care unit: A systematic review and meta-analysis. Clin Nutr. 2025 Aug;51:28-39. doi: 10.1016/j.clnu.2025.06.002. Epub 2025 Jun 6.

    PMID: 40516325BACKGROUND

MeSH Terms

Conditions

MalnutritionCritical Illness

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Azza A Eltayeb, prof

    pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Merna A Felly, Resident

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

January 10, 2028

Last Updated

September 22, 2026

Record last verified: 2026-09