The Prevalence of Malaysian Children Aged ≥ 6 to ≤ 36 Months at Risk of Anaemia

A Cross- Sectional Study on the Prevalence of Malaysian Children Aged ≥ 6 to ≤ 36 Months at Risk of Anaemia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia
• Intervention / Treatment: Diagnostic test: measuring Total Haemoglobin (SpHb) using Masimo Rad-67.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1215

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
      • Department of Paediatrics, University Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Outpatient children aged ≥ 6 months to ≤ 36 months at MCHC accompanied by their primary caretaker who could be parents/ grandparents / relatives.
2. Written consent from parent(s) / grandparents / relatives / legally acceptable representative(s) who are the primary caretaker of the child, who themselves are aged ≥18 years, to consent and comply with the terms and conditions of the study.

Exclusion Criteria:

1. Children with any medical condition that, in the opinion of the Investigator, would not be suitable for enrolment into the study. The examples of such medical condition include: severe chromosome / genetic abnormalities, severe neurological disorders which may cause feeding difficulties, severe congenital heart disease, severe acute malnutrition, gastrointestinal disorders that result in malabsorption (e.g. coeliac disease), malignancies, and any other medical condition in which the Investigator considers that interventions to increase nutritional intake may not be effective in improving weight gain and nutritional status.
2. Children participating in any other studies involving iron fortified foods / supplementation.
3. Parent(s) / legally acceptable representative(s) who have insufficient ability to understand or communicate in English and / or Bahasa Malaysia and / or Chinese (Mandarin).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Diagnostic test: measuring Total Haemoglobin (SpHb) using Masimo Rad-67.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Danone Specialized Nutrition (M) Sdn Bhd
• Investigators: Principal Investigator: Muhammad Yazid Jalaludin, Department of Paediatrics, University Malaya Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): December 2, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: anaemia; paediatrics
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: MD21-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes