An interventional study of High dense nutrients formula and Pediatric Nutrition Care (PNC) in Growth Failure, sponsored by Danone Specialized Nutrition Indonesia. Active, not recruiting at 1 site in Indonesia. Open to participants aged 6 Months to 12 Months. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Danone Specialized Nutrition Indonesia (part of Danone) · Not applicable, Interventional, and Treatment
Study will be done by consortium of pediatrician from Indonesia, Japan, and Germany. This team will act as leaders while the field assistant will consist of nutritionist and general practitioner. The chosen primary endpoint is the improvement of weight for age (grams) of the sample after one month of intervention. Participants are weight faltering babies aged 6-12 months at study entry, with the weight increments below P 15th of WHO weight increments tables whose parents agreed to be included in the study by providing written informed consent.
Study will be done by consortium of pediatrician from Indonesia, Japan, and Germany. This team will act as leaders while the field assistant will consist of nutritionist and general practitioner. The chosen primary endpoint is the improvement of weight for age (grams) of the sample after one month of intervention. Participants are weight faltering babies aged 6-12 months at study entry, with the weight increments below P 15th of WHO weight increments tables whose parents agreed to be included in the study by providing written informed consent. The investigators aim to include 2 x 94 babies for a randomized control trial study residing in Makassar, South Sulawesi. They will be selected and enrolled after matching for age and sex. All babies will be examined in for their nutritional status, demographics, medical history, preexisting conditions, medication use, their dietary analysis (by 3-days food recalls), gut microbiota and fecal metabolome. The direct (face to face) monitoring sessions will be conducted at the enrollment, one month, two months and at the end of the study (at the third month) by giving routine clinical care to all enrolled babies, which included physical examination, growth monitoring, health, and nutrition education (counseling on infant and young child feeding practices, personal hygiene, and hand washing). This monitoring session will be held by practitioner and nutritionist. Subjects will be chosen based of the inclusion \& exclusion criteria. There are two research groups. The first group will be given pediatric nutrition care (PNC). In this group parents will receive nutritional advice about how many calories are needed, the type and form of food that can be given so that the baby can gain weight accordingly. In the second group, subject will receive PNC and food for special medically purposes/FSMP that will be given according to daily calorie needs which are determined based on ideal body weight (BB) according to body length. In general, FSMP will be given 3 times a day, according to the needs of each subject. Parents will be taught about preparation of FSMP e.g., dissolving and the correct amount of product (image will be attached in the appendix). FSMP will be given during the research period and will be discontinued when participant do not need it anymore.
Infants whose weight gain is below the 5th percentile of the WHO weight gain table and infants who are already mildly undernourished will be immediately given PNC + FSMP and not included in the PNC group. At the beginning of the study, parents will be asked about the type of food and milk consumed, amount and eating patterns, the incidence of illness such as fever, cough, runny nose, diarrhea, vomiting, sleep, and the general condition of the baby. Research team till measure body weight, length, head circumference and take the feces for microbiota and metabolome examination before intervention. Feces obtained will be stored at temperatures below 5ºC for a maximum of 24 hours. Subjects will be monitored for 4 weeks. In the fourth weeks there will be an examination of body weight, length, episodes of illness and stool collection for the second examination of microbiota and metabolome. At the end of the first month intervention, the investigators will ask the parents for giving permission to draw the blood from their children to see the plasma metabolome.
If within 4 weeks, the baby has gained a good weight gain according to the existing table (above P 15), then the subject does not need to take FSMP again but will continue to be monitored every month to prevent the second growth faltering event. If the baby is initially in the PNC group and does not gain good weight, PNC + FSMP will be given. The intervention and monitoring will be done for a total of 12 weeks. Every week, the total volume that had been consumed will be monitored by the field assistant by phone. Product acceptance questionnaires for the FSMP product will be assessed using a questionnaire during the monitoring visits at visit 1, 2 and 3. The occurrence of adverse events and medication use was recorded throughout the whole study period. All subjects will be provided with BPJS insurance during the study period up to one month after the study is completed.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's planned enrollment of 188 is above the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Danone Specialized Nutrition Indonesia is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This first group will be given pediatric nutrition care (PNC) in visit 0. In this group parents will receive nutritional advice about how many calories are needed, the type and form of food that can be given so that the baby can gain weight accordingly.
Other: Pediatric Nutrition Care (PNC)
In this second group, subject will receive PNC in visit 0 and food for special medically purposes/FSMP that will be given according to daily calorie needs which are determined based on ideal body weight (BB) according to body length. In general, FSMP will be given 3 times a day, according to the needs of each subject. Parents will be taught about preparation of FSMP e.g. dissolving and the correct amount of product (image will be attached in the appendix). FSMP will be given during the research period and will be discontinued when not needed anymore.
Other: High dense nutrients formula · Other: Pediatric Nutrition Care (PNC)
High dense nutrients formula: Powder based Infant formula with High Nutrients' Density with energy density of 100 kcal/100ml and for Pediatric Nutrition Care: A medical service to understand nutritional status, problems related to the feeding process and clinical diagnosis of the patient.
Also known as: food for special medically purposes
Pediatric Nutrition Care: A medical service to understand nutritional status, problems related to the feeding process and clinical diagnosis of the patient.
Weight increment difference in grams
to look for the relative efficacy of PNC and PNC + FSMP (SGM 100) on the weight increments
Time frame: one month
weight increment percentile
to look for the improvement of weight increments percentile of all subjects measured from time to time during the study period
Time frame: during study period (3 months)
length increments in cm
to look length increments of all subjects measured from time to time during the study period
Time frame: during study period (3 months)
body mass index in kg/m^2
to look length increments and body mass index alteration of all subjects measured from time to time during the study period
Time frame: during study period (3 months)
Composition (proportion) of each type of microorganisms in fecal
changes of fecal microbiome composition (proportion of microorganisms' type) in control and intervention group
Time frame: baseline, one month
level of metabolites in faecal (faecal metabolome)
level of metabolites in untargetted faecal metabolome analysis measured by LCMS in control and intervention group
Time frame: baseline and one month in the study
Number of children with existence of any medical health history to understand any related risk factors of weight faltering (obtained from anamnesis and physical examination)
identify medical health history (obtained from anamnesis and physical examination) to understand any related risk factors of weight faltering during study period and from health history starting from prenatal, including their delivery mode, gestational age
Time frame: at screening, baseline, one month, second month and third month
Amount of Energy intake of children
quantifying amount of energy intake among children in the study measured by dietary recall using interview
Time frame: at baseline, one month, and second month of the study
Number of children who accept the product
acceptance of the product during study period measured by the proportion of respondents who answer all questions in acceptance questionnaire with agree or strongly agree
Time frame: during study period (at one month, second month and third month)
Number of children who tolerate the product
tolerance of the product during study period measured by the proportion of children who were consuming the recommended amount of product during the study without any adverse event related to the consumption
Time frame: during study period (at one month, second month and third month)
compliance of the product consumption
compliance of the product consumption during study period measured by the proportion of children who were consuming the recommended amount of product during the study
Time frame: during study period (at one month, second month and third month)
infection episodes
number of infection incidence experienced by children during study period
Time frame: during study period (at one month, second month and third month)
sleep quality
the mean duration of sleep of children during study period recorded by a diary during study period (by calculating the mean duration of the sleep)
Time frame: during study period (at one month, second month and third month)
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in May 2023, 9 months.
Of 18 interventional studies with no phase under Failure to Thrive, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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