Lower calorie feeding for severely malnourished children
Reduced Calorie Feeds in the Early Management of Ill Severely Malnourished Children: a Phase I Clinical Trial
This study is testing if giving severely malnourished children lower calorie feeds can help them survive better while they are sick compared to the usual higher calorie feeds.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 2 sites (Dhaka and 1 other locations) |
| Trial ID | NCT06846749 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if providing lower calorie feeds during the initial treatment phase can improve survival rates in severely malnourished children who are ill. Researchers will compare two types of lower calorie feeds (F50 and F35) against the standard feed (F75) to assess safety and effectiveness in preventing low blood sugar and worsening clinical symptoms. Participants will be closely monitored during their hospital stay until they are stable enough for higher calorie feeds to promote weight gain.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to under 59 months who are hospitalized with acute illness and diagnosed with severe malnutrition.
Not a fit: Patients with oedematous malnutrition or those requiring immediate cardiac or respiratory resuscitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and survival rates in severely malnourished children.
How similar studies have performed: Other studies have shown success with similar nutritional interventions in malnourished populations, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dhaka and 1 other locations
- International Centre for Diarrheal Disease Research — Dhaka, Bangladesh (Recruiting)
- Queen Elizabeth Central Hospital — Blantyre, Malawi (Not_yet_recruiting)
Study contacts
- Study coordinator: Robert Bandsma, MD PhD
- Email: robert.bandsma@sickkids.ca
- Phone: 416-813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.