Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorUniversitas Indonesia
About this trial
This study is a hospital-based, prospective, multicentre cohort study (the HOSPIC-6 Study) that will follow infants under 6 months of age who are admitted to pediatric or perinatology wards with acute malnutrition, diagnosed according to the 2023 WHO criteria. The study will take place at Cipto Mangunkusumo Hospital (RSCM) in Jakarta, Indonesia, together with other hospitals all over Indonesia joining the HOSPIC-6 network, over a period of about one year.
The purpose of this study is to:
1. Describe how common acute malnutrition is among infants under 6 months admitted to these hospitals 2. Observe what happens to these infants during nutrition treatment: whether they recover, whether their growth improves, or whether they experience complications or death. 3. Look at the factors associated with succesful nutrition therapy outcomes.
After enrolment, each infant's weight, length, head circumference, and mid-upper arm circumference will be measured using standardized techniques, along with information about their birth history, feeding history, and any other illnesses. These measurements, along with details of the nutrition therapy provided, will be repeated on day 3, day 7, and then weekly until the infant is discharged from the hospital. All data will be recorded in a secure, password-protected electronic database (REDCap). No experimental drug or intervention will be given as part of this study; infants will receive the nutrition care that their treating doctors already provide as standard practice, and the study will only observe and record what happens.
The information gathered from this study is expected to help doctors and health authorities better understand the scale of this problem in Indonesia and to support the development of clearer, evidence-based feeding and calorie guidelines for the treatment of acute malnutrition in infants under 6 months of age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants under 6 months of age admitted to inpatient care who meet the WHO 2023 criteria for acute malnutrition.
For infants aged 0-1 month, criteria include a documented weekly weight gain of less than 200 grams, or failure to return to birth weight by 2 weeks of chronological age.
Weight-for-age less than -2 SD
Weight-for-length less than -2 SD, or
Disqualifiers
Infants with inborn error of metabolism
Infant with syndromic condition (e.g., Down syndrome, Silver-Russell syndrome, Turner syndrome, Klinefelter syndrome, or other diagnosed syndromic conditions),
Infant with anatomical abnormality affecting body weight, such as hydrocephalus.
Trial population
Infants under 6 months of age admitted to inpatient care in pediatric and perinatology wards at RSCM and partner hospitals/centers that join the HOSPIC-6 collaborative network.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNo intervention (observational study)
Treatment groups
1,780 Participants
are divided into 1 treatment groupGroup A: Infants Under 6 Months of Age with Acute Malnutrition based on WHO 2023 Guideline1 intervention
Trial outcomes
Primary outcomes
1
Change in nutritional status
Change in nutritional status as indicated by change in z-score toward the age- and sex-specific reference, as determined using the PediTools online calculator. The 24-week upper bound is to accommodate prolonged hospitalization in infants with severe comorbidities requiring extended nutritional stabilization.
Time frame
Baseline, Day 3, Day 7, and weekly thereafter through hospital discharge, up to 24 weeks, whichever comes first.Secondary outcomes
1
All-cause mortality
Proportion of infants under 6 months with acute malnutrition who died from any cause during hospitalization.
Time frame
From baseline until death or hospital discharge, up to 24 weeks.Other outcomes
1
Average Daily Caloric Intake
Mean daily caloric intake achieved (kcal/kgBW/day), recorded from nutritional therapy documentation at each assessment point.
Time frame
Baseline, Day 3, Day 7, and weekly thereafter through hospital discharge, up to 24 weeks, whichever comes first.Sponsors and contacts
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Source ClinicalTrials.gov