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The main purpose of this study is to determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using a non-invasive haemoglobin assessment. Eligible subjects, and their parent(s) / legally acceptable representative(s) where applicable, who fulfil all the inclusion and none of the exclusion criteria will be enrolled into the study. Parameters will be recorded during the subjects visit at the MCHC using a self-administered 24-hour Diet Recall. Demographics and subject / family characteristics will be recorded at this visit by using questionnaire built into Iron Strong app which act as a data collection tool.For subjects with haemoglobin level <12 g/dL, the subject will be considered "at risk of anaemia" and as a standard operating procedure, the child will be referred to HCPs for further clinical assessment.
Eligible subjects, and their parent(s) / legally acceptable representative(s) where applicable, who fulfil all the inclusion and none of the exclusion criteria will be enrolled into the study. Recruitment at the study sites will continue until required number subjects have been enrolled.
Parameters will be recorded during the subjects visit at the MCHC. Parent(s) / legally acceptable representative(s) will be asked to report subject dietary intake using a self-administered 24-hour Diet Recall. A Site Research Assistant will be present to assist with the completion of the 24-hour Diet Recall.
Demographics and subject / family characteristics will be recorded at this visit by using questionnaire built into Iron Strong app. The Iron Strong app, as a data collection tool includes an optical character recognition (OCR) model that allows user (by taking a picture) to accurately predicts all units and digits on Masimo Rad-67 device and store the data within the app / server. The access of the application is only possible via email invitation to Site Investigator / Research Assistant.
Masimo Rad-67 is a non-invasive device for total haemoglobin screening. A clip with sensor attached to Masimo Rad-67 will be place on the child's finger / toe, reading will take approximately 30 seconds.
For subjects with haemoglobin level <12 g/dL, the subject will be considered "at risk of anaemia" and as a standard operating procedure, the child will be referred to HCPs for further clinical assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malaysian children aged ≥ 6 months to ≤ 36 months | The study population consists of Malaysian children aged ≥ 6 months to ≤ 36 months seen at Mother and Child Health Clinic (MCHC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measuring Total Haemoglobin (SpHb) using Masimo Rad-67. | Diagnostic Test | To determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using Masimo Rad-67. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67. | Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Haemoglobin among Malaysian children aged ≥ 6 to ≤ 36 months. Proportion of Malaysia children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) < 11g/dL vs ≥11g/dL measured using Masimo Rad-67. | Mean Haemoglobin among Malaysian children aged ≥ 6 to ≤ 36 months. Proportion of Malaysia children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) < 11g/dL vs ≥11g/dL measured using Masimo Rad-67. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of Malaysian children aged ≥ 6 months to ≤ 36 months seen at Mother and Child Health Clinic (MCHC). A sample size of 1200 will be required after accounting for 10% each of screen failures and dropouts. Any withdrawn subjects /screen failures will be replaced.
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Yazid Jalaludin | Department of Paediatrics, University Malaya Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, University Malaya Medical Centre | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
This study is an industry sponsored research. Danone Specialized Nutrition (Malaysia) Sdn Bhd being the sponsor of the research is the exclusive owner of the study data as mutually agreed in the Clinical Trial Agreement. Investigators can be part of publication team and author of the manuscript as mutually agreed in the Clinical Trial Agreement.
Proposals from Investigators for access to additional study data research,manuscript writing, knowledge sharing, reporting to ministries etc purposes can be given with permission by Danone Malaysia when applicable.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Socio-demographic characteristics of child and parent(s) assisted and administered by Site Investigator. | Socio-demographic characteristics of child and parent(s) assisted and administered by Site Investigator. | 6 months |
| Dietary intake using self-administered 24-hour Diet Recall interviewed and recorded by RA / Site Investigator. | Dietary intake using self-administered 24-hour Diet Recall interviewed and recorded by RA / Site Investigator. | 6 months |
| Height / Length & weight recorded by RA / Site Investigator for their corresponding WHO Weight for Age, Height for Age Z-Scores for data analysis. | Height / Length & weight recorded by RA / Site Investigator for their corresponding WHO Weight for Age, Height for Age Z-Scores for data analysis. | 6 months |
| Correlation between nutritional status (WHO Z-Scores, Total Energy intake / day, Protein intake / day, Iron intake / day) and risk of anaemia among Malaysian children aged ≥ 6 to ≤ 36 months. | Correlation between nutritional status (WHO Z-Scores, Total Energy intake / day, Protein intake / day, Iron intake / day) and risk of anaemia among Malaysian children aged ≥ 6 to ≤ 36 months. | 6 months |