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

NCT ID: NCT05181436

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-19
• Study Completion Date: 2023-02-28

Brief Summary

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.

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.

Conditions

Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

measuring Total Haemoglobin (SpHb) using Masimo Rad-67.

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Specialized Nutrition (M) Sdn Bhd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Yazid Jalaludin

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics, University Malaya Medical Centre

Locations

Department of Paediatrics, University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Other Identifiers

MD21-002

Identifier Type: -

Identifier Source: org_study_id