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Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)

Study acronym: HOSPIC-6
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Universitas Indonesia

Record History

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  1. Minor Study sites: 5 to 6
  2. Minor Study sites: 4 to 5
  3. Notable Primary endpoint(s) modified
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07831343
Lead Sponsor Universitas Indonesia
Conditions
(from sponsor)
Malnutrition, Infant, Malnutrition
Related terms Cachexia, Infant Nutrition Disorders, Malnutrition
Enrollment 1,780 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov