NCT05816278

Brief Summary

Anemia is one of the major global problems that continues to this day. According to World Health Organization (WHO) data, anemia is found in 1.62 billion people or equivalent to 24.8% of the world's population while, the prevalence of anemia in children under 6 years of age in Indonesia reached 38.4%. Anemia, if undiagnosed or untreated for a long period of time can lead to multiorgan failure. The cardiovascular system is the most commonly affected system in chronic anemia. Between one-third and two-thirds of patients with severe anemia have cardiomegaly and this will return to normal within a few weeks after the anemia is well managed. This abnormality can be evaluated on chest radiograph or echocardiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

April 2, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

April 2, 2023

Last Update Submit

March 21, 2026

Conditions

Anemia in ChildrenCardiomegaly

Outcome Measures

Primary Outcomes (2)

  • Anemia

    Diagnosis of anemia based on Hb levels according to WHO classification

    April 2023 - September 2023

  • Cardiomegaly

    Diagnosis of cardiomegaly based on chest radiograph and echocardiography

    April 2023 - September 2023

Eligibility Criteria

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

All children diagnosed with anemia; whether from the pediatric ward and pediatric cardiology outpatient clinic

You may qualify if:

  • Anemia patients aging maximum 18 years old
  • Anemia patients who had undergone chest radiograph and echocardiography

You may not qualify if:

  • Anemia patients who had undergone definitive surgery
  • Anemia patients who had took iron supplementation in the last 3 months
  • Anemia patients who had other anemic conditions such as chronic kidney disease or hemolytic anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Sumatera Utara

Medan, North Sumatera, 20155, Indonesia

Location

MeSH Terms

Conditions

Cardiomegaly

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Putri Amelia, M.Ked (Ped), Sp.A(K)

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 18, 2023

Study Start

May 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 20, 2023

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

ID(1)