Growth; Stunting, NutritionalNCT04515264
Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months
An observational study of Growth; Stunting, Nutritional, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth; Stunting, Nutritional
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2021to 22 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Target population of this study are post partum inpatient mothers in Government \& Private Hospital in Jakarta between July - Agustus 2020.
Who may be able to join
- Mother :
- Age of 18-45 year at the time of delivery
- Willing to breastfed at least up to 4 month
- Singleton birth
Who cannot join
- Mother :
- Type 1 or 2 diabetes before or during pregnancy
- Presenting conditions that contraindicate breastfeeding
- Smoking
- Infant :
- Congenital illness or malformation that could affect growth
- Infants received water or any other food besides breast milk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months. a Longitudinal Study
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.
Read the 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
- screening : description of the aims, benefits and procedures of the study, filling the informed consent, screening based on inclusion and exclusion criteria.
- 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).
- Data analysis :
- 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.
- 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.
- 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.
- Multivariate analysis will be conduct by linear regression model.
- Conditions
- Growth; Stunting, Nutritional
- Keywords
- human milk oligosaccharides
- Medical subject headings
- Growth Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline WLZ at 4 months.
Weight velocity
Comparing the infant weight gain with weight velocity chart from WHO
Measured: Change from baseline weight velocity at 2 months.
Weight velocity
Comparing the infant weight gain with weight velocity chart from WHO
Measured: Change from baseline weight velocity at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Aug 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth; Stunting, NutritionalStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth nutrition indonesia
- Responsible party
- Principal investigator, Verawati Sudarma, Universitas Indonesia
- Investigators
- Verawati Sudarma, Master, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515264
- Sponsor's protocol ID
- HMOs Indonesia 1
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data (IPD) will be shared based on request
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months. a Longitudinal Study
- ClinicalTrials.gov ID
- NCT04515264
- Acronym / sponsor ID
- HMOs Indonesia 1
- Conditions
- Growth; Stunting, Nutritional
- Keywords
- human milk oligosaccharides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Wyeth nutrition indonesia
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- screening : description of the aims, benefits and procedures of the study, filling the informed consent, screening based on inclusion and exclusion criteria.
- 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).
- Data analysis :
- 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.
- 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.
- 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.
- Multivariate analysis will be conduct by linear regression model.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Target population of this study are post partum inpatient mothers in Government \& Private Hospital in Jakarta between July - Agustus 2020.
Key inclusion criteria (4 listed)
- Age of 18-45 year at the time of delivery
- Willing to breastfed at least up to 4 month
- Singleton birth
Key exclusion criteria (7 listed)
- Mother :
- Infant :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight for Age Z score (WAZ)
Time frame: Change from baseline WAZ at 2 months.
weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.
Weight for Age Z score (WAZ)
Time frame: Change from baseline WAZ at 4 months.
weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.
Weight for Length Z score (WLZ)
Time frame: Change from baseline WLZ at 2 months.
weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.
Weight for Length Z score (WLZ)
Time frame: Change from baseline WLZ at 4 months.
weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.
Weight velocity
Time frame: Change from baseline weight velocity at 2 months.
Comparing the infant weight gain with weight velocity chart from WHO
Weight velocity
Time frame: Change from baseline weight velocity at 4 months.
Comparing the infant weight gain with weight velocity chart from WHO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No. The Individual participant data (IPD) will be shared based on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verawati Sudarma, Master principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth; Stunting, Nutritional, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight for Age Z score (WAZ) (time frame: Change from baseline WAZ at 2 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.