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RECRUITINGPhase 1INTERVENTIONAL

Slow Introduction of Nutrition for Ill Malnourished Children

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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" Who Should NOT Join This Trial: - 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 willing to sign a consent form 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

F75 milk feeds

Standard 'F75' (75 kcal/100 ml) 95 kcal/kg/day 12.05 mg/kg/min glucose

DIETARY_SUPPLEMENT

F50 milk feeds

Reduced caloric 'F50' (50kcal/100ml) 63 kcal/kg/day 8.03mg/kg/min glucose

DIETARY_SUPPLEMENT

F35 milk feeds

Reduced caloric 'F35' (35 kcal/100ml) * 47 kcal/kg/day * 5.62 mg/kg/min glucose

Locations (2)

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