Acute Malnutrition in Infants Under 6 Months of Age Based on the 2023 WHO Criteria and Influencing Factors: A Multicenter Prospective Cohort in Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,780
- 试验地点
- 4
- 主要终点
- Improvement in nutritional status
研究概览
简要总结
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:
- Describe how common acute malnutrition is among infants under 6 months admitted to these hospitals
- Observe what happens to these infants during nutrition treatment: whether they recover, whether their growth improves, or whether they experience complications or death.
- 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.
详细描述
Rationale and Scientific Background Acute malnutrition in infants younger than 6 months has historically received less attention than malnutrition in older children, both in global nutrition programs and in national health monitoring systems. The World Health Organization (WHO) 2013 guideline on the management of severe acute malnutrition addressed infants under 6 months only briefly, largely extrapolating recommendations developed for older children. The WHO 2023 guideline expanded this guidance substantially, introducing the broader concept of infants "at risk of poor growth and development" alongside the traditional anthropometric thresholds (weight-for-age, weight-for-length, and mid-upper arm circumference).
National data support the clinical relevance of this population. The 2023 Indonesian Health Survey / Survey Kesehatan Indonesia (SKI) reported a 2.6% prevalence of acute malnutrition among infants aged 0-5 months, and the 2024 Indonesian Nutritional Status Survey / Survei Status Gizi Indonesia (SSGI) reported 1.6% in the same age group - both higher than prevalence figures reported for children 24 months and older. Institutional data from Cipto Mangunkusumo Hospital / Rumah Sakit Ciptomangunkusumo (RSCM) identified 282 infants under 6 months admitted with severe malnutrition in 2024 alone.
Despite this burden, the current WHO 2023 guideline does not specify detailed, concrete caloric targets for nutritional therapy in this age group, and there are no Indonesian studies linking specific nutrition therapy approaches, patient risk factors, and treatment outcomes in this population. This creates uncertainty in day-to-day clinical decision-making and a gap in the evidence needed to develop a standardized, locally relevant treatment protocol. This study (HOSPIC-6) was designed to generate multicenter, prospective, hospital-based evidence to help close this gap.
Research Questions and Objectives
This study is designed to address three research questions:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Infants Under 6 Months of Age with Acute Malnutrition based on WHO 2023 Guideline
Infants under 6 months of age fulfilling acute malnutrition criteria based on WHO 2023
干预措施: Not applicable- observational study (Other)
结局指标
主要结局
Improvement in nutritional status
时间窗: Baseline, Day 3, Day 7, and weekly thereafter through hospital discharge, up to 24 weeks, whichever comes first.
Improvement in nutritional status as indicated by an increase in the z-score, 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.
次要结局
- All-cause mortality(From baseline until death or hospital discharge, up to 24 weeks.)
研究者
dr. Yoga Devaera
Medical Doctor, Pediatrician, PhD
Universitas Indonesia