An observational study in Growth; Stunting, Nutritional, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to participants aged 2 Weeks to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Universitas Indonesia · Observational
The breastfeeding rates globally in Indonesia generally remain low with only 40% or less infants aged 6 months are exclusively breastfed. Available national data in 2018 showed the proportion of wasted in children under 5 years old was 6.7%, while 3.5% children were severely wasted. This data showed improvement compared data in 2007 and 2013. While proportion children under 2 years old with stunted and severly stunted was 29.9%. As the third most abundant group of compounds in human milk, after lactose (70 g/L) and lipids (40 g/L), human milk oligosaccharides (HMOs) never been study in Indonesia. HMOs amount and diversity influenced by non modifiable and modifiable factors. The maternal phenotypes, the α-1-2-fucosyltransferase (FUT-2) gene and the α-1-3-4-fucosyltransferase (FUT-3) gene divided the mother into secretor (Se+) and non secretor (Se-) and Le+ or Le-). Studies showed the breastfed infants of non secretor mothers secrete lower HMOs than secretor mothers. By many functions in HMOs such as prebiotic, anti infection, modulate immunity, it is thought that HMOs can influence infant growth. The hypothesis of this study is to show the associations between maternal factors (secretor gene status/FUT-2 gene, lewis gene status/FUT-3 gene, gestational age and gestational weight gain) with HMOs profiles and growth indicators of infants aged 0-4 months.
This study is a prospective longitudinal study to analyze the association between HMOs profiles and growth indicators of infants age 0-4 months. In this longitudinal study, the human milk, anthropometry assessment and questionnaires will be collect in the 0, 2, 4 month of age. Gestational age and birth weight will be obtain from the medical status upon enrollment.
The study will be conduct in Government \& Private Hospital in Jakarta between Juli - December 2020. Based on sample size calculation, the total minimal samples are 120 samples. Subjects recruitment will be based on nonprobabilistic consecutive sampling to post partum inpatient mothers in Government \& Private Hospital in Jakarta between Juli - December 2020.
Study forms consist of study information, informed consent, screening form, baseline data, follow up form and laboratory result form. The tools requirements are among others Seca 728 electronic infant scale, Anthropometry Plus (AnthroPlus) Software, World Health Organization (WHO) growth velocity chart, Questionnaires, Thermometer, 15 mL polypropylene tube, Disposable gloves and vacuum bag with dry ice. The specimens obtain for this study are 15 mL venous blood for genotyping and 10 mL breast milk (0, 2, 4 month).
After obtaining clearance from Ethical Committee of the Faculty of Medicine University of Indonesia, the post partum mothers will be presented with Form A (study information form). Patients will be informed about the aim, benefits and procedures of the study. If patients agree, she will have to sign the informed consent (Form B).
Study phases consists of
Data collection :
Data analysis :
172 studies on the registry are indexed under Growth Disorders; 24 are open to participants now.
This study's enrollment of 120 is below the median of 203 across 68 observational studies indexed under Growth Disorders.
Browse Growth Disorders studies →Universitas Indonesia is the lead sponsor of 29 studies on the registry; 12 are open to participants now.
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Target population of this study are post partum inpatient mothers in Government \& Private Hospital in Jakarta between July - Agustus 2020.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Mother :
Exclusion Criteria:
Mother :
Infant :
Weight for Age Z score (WAZ)
weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.
Time frame: Change from baseline WAZ at 2 months.
Weight for Age Z score (WAZ)
weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.
Time frame: Change from baseline WAZ at 4 months.
Weight for Length Z score (WLZ)
weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.
Time frame: Change from baseline WLZ at 2 months.
Weight for Length Z score (WLZ)
weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.
Time frame: Change from baseline WLZ at 4 months.
Weight velocity
Comparing the infant weight gain with weight velocity chart from WHO
Time frame: Change from baseline weight velocity at 2 months.
Weight velocity
Comparing the infant weight gain with weight velocity chart from WHO
Time frame: Change from baseline weight velocity at 4 months.
Plan to share: No — The Individual participant data (IPD) will be shared based on request
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Universitas Indonesia