- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515264
Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months
The Association Between Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months. a Longitudinal Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia
- Universitas Indonesia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Mother :
- Age of 18-45 year at the time of delivery
- Willing to breastfed at least up to 4 month
- Singleton birth
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline WAZ at 2 months.
|
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.
|
Change from baseline WAZ at 4 months.
|
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.
|
Change from baseline WLZ at 2 months.
|
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.
|
Change from baseline WLZ at 4 months.
|
Weight velocity
Time Frame: Change from baseline weight velocity at 2 months.
|
Comparing the infant weight gain with weight velocity chart from WHO
|
Change from baseline weight velocity at 2 months.
|
Weight velocity
Time Frame: Change from baseline weight velocity at 4 months.
|
Comparing the infant weight gain with weight velocity chart from WHO
|
Change from baseline weight velocity at 4 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Verawati Sudarma, Master, Indonesia University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMOs Indonesia 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Growth; Stunting, Nutritional
-
University of CopenhagenUniversity of Aarhus; Arla FoodsCompletedGrowth Acceleration | Growth; Stunting, NutritionalDenmark
-
Danone Asia Pacific Holdings Pte, Ltd.KK Women's and Children's HospitalCompletedGrowth; Stunting, NutritionalSingapore
-
Swiss Federal Institute of TechnologyBRAC University; HarvestPlusCompletedZinc Deficiency | Growth; Stunting, NutritionalSwitzerland, Bangladesh
-
Andalas UniversityIndonesia UniversityCompletedGastrointestinal Microbiome | Growth; Stunting, Nutritional | Immunoglobulin AIndonesia
-
University of WashingtonFrankel Family Foundation; Stewardship FoundationActive, not recruitingBreastfeeding, Exclusive | Immunization; Infection | Growth; Stunting, NutritionalEthiopia
-
International Centre for Diarrhoeal Disease Research...University of WashingtonCompletedNutritional StuntingBangladesh
-
Washington University School of MedicineKamuzu University of Health Sciences; Project Peanut Butter, MalawiCompletedNutritional StuntingMalawi
-
University of North Carolina, Chapel HillUniversity of California, Davis; Bill and Melinda Gates Foundation; Kinshasa...CompletedMalnutrition | Stunting of GrowthCongo
-
Johns Hopkins Bloomberg School of Public HealthEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAnemia | Growth; Stunting, NutritionalZimbabwe
-
University of South CarolinaHelen Keller InternationalCompleted