Status:
ACTIVE_NOT_RECRUITING
Growth Faltering Intervention Using Pediatric Nutritional Care (PNC) vs.PNC& FSMP
Lead Sponsor:
Danone Specialized Nutrition Indonesia
Collaborating Sponsors:
Hasanuddin University
RIKEN
Conditions:
Growth Failure
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Weight faltering babies (weight increments below percentile 15th of weight increments table WHO age 6-12 month-old with good nutritional or mild undernutrition status
- Have a growth chart monitoring (weight, length and head circumference) at least one time (at birth).
- Have the data of height and weight from father and mother (genetic height potential)
- No major congenital anomaly, severely stunted at birth, not having thyroid problem, not suffered from prominent gastrointestinal diseases, severe diseases at the time of inclusion (severe pneumonia, severe dehydration, etc)
- Not suffered from parasitic manifestation by examining the faecel sample at the time of recruitment
- Parents want to follow the study by signing the informed consent
Exclusion
- Subjects with stunting
- Subject in the severe disease condition at the time of recruitment
- Severe acute malnutrition
- Parents do not want to participate in the study
- Presence of cow's milk allergy
- Presence of lactose intolerance
- Presence of galactosemia
- Condition needing a special diet, like major renal and hepatic dysfunction
- Have conditions that will influence the nutritional status such as moderate to severe dehydration, organomegaly, oedema.
- Babies with weight more than ideal body weight
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT05393934
Start Date
August 17 2022
End Date
December 31 2024
Last Update
February 26 2024
Active Locations (1)
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1
Hasanuddin University
Makassar, South Sulawesi, Indonesia, 90245