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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05181436
• Other study ID #: MD21-002
• Status: Active, not recruiting
• Start date: July 19, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2022
• Source: Danone Specialized Nutrition (M) Sdn Bhd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1215
• Est. completion date: February 28, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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).

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Department of Paediatrics, University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Danone Specialized Nutrition (M) Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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