NCT05181436

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,215 (actual)
• Sponsor: Danone Specialized Nutrition (M) Sdn Bhd · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-19
• Primary completion: 2022-12-02
• Completion: 2023-02-28
• First posted: 2022-01-06
• Last updated: 2022-12-22

Locations

1 site across 1 country: Malaysia

Regulatory

• FDA-regulated device study