Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months
Condition: Growth; Stunting, Nutritional
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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

        1. screening : description of the aims, benefits and procedures of the study, filling the
           informed consent, screening based on inclusion and exclusion criteria.

        2. Data collection :

             -  Interview. Interview will be done to fill information in Form C and D.

             -  Subjects selected during the screening visit will follow a 4 month study. Primary
                and secondary outcomes will be measured at 0, 2, 4 months (visit 1-2-3).

        3. Data analysis :

             1. All data will be edited, coded and entry to the computer. The Statistical Package
                for the Social Sciences (SPSS) for windows version 20.0 will be use for data
                analyzing.

             2. Univariate analysis will be conduct to know the distribution of each variables.
                Test of normality of the data will be perform with Kolmogorov-Smirnov test at the
                significance level p>0.05 as normally distributed data. The continuous data will be
                present as mean ± standard deviation and for categorical data in n (%) for normally
                distributed data and geometric mean ± standard deviation forn non-normally
                distributed data.

             3. For bivariate analysis, Pearson correlation test will be performed if the data is
                normally distributed or Spearman Rank test if the data is non-normally distributed.
                Reference for rho value show in Table 3.3.

             4. Multivariate analysis will be conduct by linear regression model.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Target population of this study are post partum inpatient mothers in Government & Private
        Hospital in Jakarta between July - Agustus 2020.
      
Biospecimen description: 
      whole blood, breast milk
    
Keywords: human milk oligosaccharides