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

NCT05393934 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-02-26

No results posted yet for this study

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

Interventions

OTHER

High dense nutrients formula

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.

OTHER

Pediatric Nutrition Care (PNC)

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

Sponsors & Collaborators

  • Hasanuddin University

    collaborator OTHER

  • RIKEN

    collaborator OTHER

  • LMU Klinikum

    collaborator OTHER

  • Danone Specialized Nutrition Indonesia

    lead INDUSTRY

Principal Investigators

  • Conny Tanjung, MD, PhD · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2023-05-23
Completion
2024-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393934 on ClinicalTrials.gov