High-calorie oral nutrition for growth and development in malnourished young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, controlled trial enrolls children aged 1–3 years who are underweight or wasted and randomizes them to receive nutritional education plus daily high-calorie oral nutritional supplements (providing about 30% of energy needs) or to a control group receiving nutritional education and dietary instruction. Investigators will track body proportion, weight, linear growth patterns, neuropsychological development, gut health, immune function, quality of life, and safety outcomes over scheduled follow-up visits. Randomization uses a competitive entry method across participating pediatric centers in China, with regular monitoring of dietary intake and adverse events. The trial aims to generate data to guide clinical intervention strategies for malnourished Chinese children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 1-3 years
* BMI for Age Z-score\<-2
* Height-for-age z score\<-2
* Total daily energy intake\<75% of recommended nutrient intake
* The child's guardian is willing to participate in this study and sign an informed consent form.

Exclusion Criteria:

* Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection)
* Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.)
* Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.)
* Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment
* Allergy or contraindication to any of the ingredients in the high-energy total nutrition formula used in this study
* Have used high-energy enteral nutrition preparations for the last 3 months

Where it's running

• Anhui Provincial Children's Hospital
  Hefei, Anhui, China Recruiting
• Children's Hospital of The Capital Institute of Pediatrics
  Beijing, Beijing Municipality, China Recruiting
• The First Hospital of Jilin University
  Jilin City, Changchun, China Recruiting
• Growth, Development and Mental health of Children and Adolescence Center
  Chongqing, Chongqing Municipality, China Recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Recruiting
• Guiyang Maternity and Child Health Care Hospital
  Guiyang, Guizhou, China Recruiting

Study contacts

• Study coordinator: Li Chen, doctor
• Email: chenli2012@126.com
• Phone: 136 7762 0103

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.