Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could fewer calories save more lives? new trial for malnourished kids

NCT ID NCT06846749

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving severely malnourished children lower-calorie feeds during the first stage of hospital treatment is safe and helps them survive. About 135 children aged 6 months to 5 years will receive either a standard feed or one of two reduced-calorie feeds. Researchers will closely monitor for low blood sugar and other complications to find the safest approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age - greater than or equal to 6 months to less than 59 months (age range for which WHO guidelines were developed and where children are not expected to be exclusively breastfeeding * Admitted to hospital with acute, non-traumatic illness and having received a maximum of 2 feeds of F75 at time of enrolment * Severe malnutrition (WHZ \<-3 z-scores of the median WHO growth standards and/or MUAC \<115mm) * Accompanied by care provider able to provide written or witnessed informed consent * Primary caregiver plans to stay in the study area for the duration of the study * Having no more than one clinical sign displayed below "Clinical/Lab Feature \& Criteria" Exclusion Criteria: * Has oedematous malnutrition (excluded for this safety focused trial as fluid accumulation influences weight which is used to calculate required caloric intake) * Requires immediate cardiac/respiratory resuscitation (chest compressions/ventilation) * Clinical contraindications for enteral nutrition * Admission for traumatic or surgical indication * Weighs \<3.5kg * Presence of terminal illness likely to result in death within 6 months * Known congenital heart disease * Have had 2 documented hypoglycaemic events in hospital * More than one clinical sign displayed below "Clinical/Lab Feature \& Criteria" * Primary caregiver declines to provide informed consent Clinical/Lab Feature \& Criteria Guidelines Clinical/Lab Feature: Respiratory distress Oxygenation Criteria: "Subcostal in-drawing" or "nasal flaring" or "head-nodding" Clinical/Lab Feature: Oxygenation Criteria: "Central cyanosis" or SaO2 \<90% Clinical/Lab Feature: Circulation Criteria: Limb temperature gradient or capillary refill \>3 seconds Clinical/Lab Feature: Reduced conscious level Criteria: AVPU \< "A" Clinical/Lab Feature: Rapid pulse Criteria: Heartbeat per min \> 180 Clinical/Lab Feature: Severe anemia Criteria: Haemoglobin \< 7g/dl Clinical/Lab Feature: Hypoglycemia Criteria: Blood glucose \< 3mmol/L Clinical/Lab Feature: Abnormal temperature Criteria: Axial temperature \<36 or \>38oC Clinical/Lab Feature: Very low MUAC Criteria: MUAC \<11cm

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Malnutrition, child are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Child Nutrition Disorders Infant Nutrition Disorders nutritional deficiency disease protein-energy malnutrition refeeding syndrome Severe Acute Malnutrition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • International Centre for Diarrheal Disease Research

    Dhaka, Bangladesh

  • Queen Elizabeth Central Hospital

    Blantyre, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.