An observational study in Anemia, sponsored by Danone Specialized Nutrition (M) Sdn Bhd. Status unknown at 1 site in Malaysia. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Danone Specialized Nutrition (M) Sdn Bhd · Observational
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 1,215 is above the median of 200 across 326 observational studies indexed under Anemia.
Browse Anemia studies →Danone Specialized Nutrition (M) Sdn Bhd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danone Specialized Nutrition (M) Sdn Bhd