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Studies

Interventional Active not recruiting Phase 1

NCT06846749 on ClinicalTrials.gov

Slow Introduction of Nutrition for Ill Malnourished Children

Official title: Reduced Calorie Feeds in the Early Management of Ill Severely Malnourished Children: A Phase I Clinical Trial

  • Sponsor: Hospital for Sick Children
  • Collaborators: Canadian Institutes of Health Research (CIHR), Kamuzu University of Health Sciences, The Eleanor Crook Foundation, Children's Investment Fund Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh
  • Enrollment: 135 (Estimated)
  • Study start: 2025-02-05 (Actual)
  • Primary completion: 2026-05-31 (Estimated)
  • Study completion: 2026-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This is a parallel interventional study model, making use of the Bayesian Continual Reassessment Method to help allocate patients to the different interventional products related to the risk of hypoglycemia compared to F 75. The DSMB will be involved in decisions around continuing with a specific interventional product incorporating SAE data.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is:

Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase?

Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia).

Participants will:

* Receive one of the lower calorie feeds (F50 or F35) or the standard feed (F75) during their hospital stay.
* Be closely monitored for low blood sugar and signs for worsening of clinical symptoms.
* Be treated until they are stable and ready to be fed more calories to help them gain weight.

Conditions

  • Malnutrition, Severe Acute
  • Malnutrition, Child
  • Malnutrition, Infant

Intervention / Treatment

  • Dietary Supplement: F75 milk feeds
  • Dietary Supplement: F50 milk feeds
  • Dietary Supplement: F35 milk feeds

Primary Outcome Measures

  • Episodes of moderate hypoglycemia (During the period of F75/F50/F35 provision meaning the stabilization phase which is on average 3 days)
    The occurrence of at least one episode of moderate hypoglycemia (less than or equal to 3.0 mmol/l) during the stabilization phase as measured utilizing the Dexcom Continous Glucose Monitoring Device and/or bed-side glucometer (OneTouch).

Countries

Bangladesh, Malawi

Locations and Investigators

  • International Centre for Diarrheal Disease Research, Dhaka, Bangladesh
  • Queen Elizabeth Central Hospital, Blantyre, Malawi