Growth Faltering Intervention Using Pediatric Nutritional Care (PNC) vs.PNC& FSMP

NCT05393934 | Active Not Recruiting DMC

• 1 other identifier: 010322
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Growth Failure

Outcome Measures

Primary Outcomes (1)

• Weight increment difference in grams

  to look for the relative efficacy of PNC and PNC + FSMP (SGM 100) on the weight increments

  one month

Secondary Outcomes (12)

• weight increment percentile

  during study period (3 months)

• length increments in cm

  during study period (3 months)

• body mass index in kg/m^2

  during study period (3 months)

• Composition (proportion) of each type of microorganisms in fecal

  baseline, one month

• level of metabolites in faecal (faecal metabolome)

  baseline and one month in the study

Study Arms (2)

PNC (Pediatric Nutrition Care)

PLACEBO COMPARATOR

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)

FSMP (Food for Special Medical Purposes) & PNC (Pediatric Nutrition Care)

ACTIVE COMPARATOR

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)

Interventions

High dense nutrients formula OTHER

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

FSMP (Food for Special Medical Purposes) & PNC (Pediatric Nutrition Care)

Pediatric Nutrition Care (PNC) OTHER

Pediatric Nutrition Care: A medical service to understand nutritional status, problems related to the feeding process and clinical diagnosis of the patient.

FSMP (Food for Special Medical Purposes) & PNC (Pediatric Nutrition Care); PNC (Pediatric Nutrition Care)

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Specialized Nutrition Indonesia: lead
• Hasanuddin University: collaborator
• RIKEN: collaborator
• LMU Klinikum: collaborator

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Failure to Thrive

Interventions

Food

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Conny Tanjung, MD, PhD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non randomized and controlled study design

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: May 26, 2022
• Study Start: August 17, 2022
• Primary Completion: May 23, 2023
• Study Completion: December 31, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)