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The Prevalence of Malaysian Children Aged ≥ 6 to ≤ 36 Months at Risk of Anaemia - Trial NCT05181436

Access comprehensive clinical trial information for NCT05181436 through Pure Global AI's free database. This phase not specified trial is sponsored by Danone Specialized Nutrition (M) Sdn Bhd and is currently Active, not recruiting. The study focuses on Anemia. Target enrollment is 1215 participants.

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NCT05181436
Active, not recruiting
diagnostic test
Trial Details
ClinicalTrials.govNCT05181436
View on ClinicalTrials.gov
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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

Study Focus

Anemia

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

Observational

diagnostic test

Sponsor & Location

Danone Specialized Nutrition (M) Sdn Bhd

Kuala Lumpur, Malaysia

Timeline & Enrollment

N/A

Jul 19, 2022

Feb 28, 2023

1215 participants

Primary Outcome

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.

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.

ICD-10 Classifications

Anaemia, unspecified
Other anaemias
Other specified anaemias
Iron deficiency anaemia
Iron deficiency anaemia, unspecified

Data Source

ClinicalTrials.gov

NCT05181436

Non-Device Trial