Anemia in ChildrenNCT05816278
The Association Between Anemia and Cardiomegaly
An observational study of Anemia in Children and Cardiomegaly, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial 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%. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Anemia in Children, Cardiomegaly
- How many people
- 56 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2023to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
Study population: All children diagnosed with anemia; whether from the pediatric ward and pediatric cardiology outpatient clinic
Who may be able to join
- Anemia patients aging maximum 18 years old
- Anemia patients who had undergone chest radiograph and echocardiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Anemia (Hemoglobin Level) and Cardiomegaly Based On Chest Radiograph and Echocardiography
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.
- Conditions
- Anemia in Children, Cardiomegaly
- Medical subject headings
- Cardiomegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Diagnosis of anemia based on Hb levels according to WHO classification
Measured: April 2023 - September 2023
Cardiomegaly
Diagnosis of cardiomegaly based on chest radiograph and echocardiography
Measured: April 2023 - September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 May 2023
- Primary completion1 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putri Amelia, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816278
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Anemia (Hemoglobin Level) and Cardiomegaly Based On Chest Radiograph and Echocardiography
- ClinicalTrials.gov ID
- NCT05816278
- Acronym / sponsor ID
- 001
- Conditions
- Anemia in Children, Cardiomegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children diagnosed with anemia; whether from the pediatric ward and pediatric cardiology outpatient clinic
Key inclusion criteria (2 listed)
- Anemia patients aging maximum 18 years old
- Anemia patients who had undergone chest radiograph and echocardiography
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anemia
Time frame: April 2023 - September 2023
Diagnosis of anemia based on Hb levels according to WHO classification
Cardiomegaly
Time frame: April 2023 - September 2023
Diagnosis of cardiomegaly based on chest radiograph and echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia in Children and Cardiomegaly, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: April 2023 - September 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.