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NCT07831343
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Conditions: Malnutrition, Infant, Malnutrition
Sex: All
Ages: 1 Day – 6 Months
Healthy volunteers: No
Enrollment: 1780
Sponsor: Universitas Indonesia
Location: RSUP Dr. Kariadi Semarang Semarang Central Java
Summary
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
Inclusion criteria:
* 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.
* For infants aged 1 month to under 6 months, at least one of the following is required:
* Weight-for-age less than -2 SD
* Weight-for-length less than -2 SD, or
* Mid-upper arm circumference under 110 mm (for infants older than 6 weeks), with or without nutritional oedema, and currently receiving treatment for acute malnutrition.
* Parents or legal guardians must provide written informed consent.
Exclusion criteria:
* 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.
Drop Outs Criteria:
Participants will be considered "drop-outs" if they are discharged against medical advice or transferred to a non-participating hospital.
Source: ClinicalTrials.gov (NCT07831343). StuddyBuddy aggregates publicly available trial information.