Management of moderate malnutrition in children presented with acute illness

Phase 3

• Conditions: Health Condition 1: E440- Moderate protein-calorie malnutrition

• Registration Number: CTRI/2023/11/060203
• Lead Sponsor: Center for Public Health Kinetics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age 6-24 months, and

2.Moderately wasted i.e. WLZ =-2 and > -3 or MUAC < 125 mm and > 115 mm, and

3.Presenting with any of the following acute illnesses at a facility out-patient clinic or discharged from hospital after <7d for any of the following:

a.diarrhea, defined as 3 or more loose or watery

stools (with or without blood) in the previous

24 hours, and no dehydration on assessment. If

the child has dehydration, the dehydration will

be treated re-assessing for recruitment, or

b.pneumonia, defined as presence before of fast

breathing or chest indrawing, or

c.Non-malarial fever, defined as reported or

measured (= 38?C) fever of >3 days but < 7 days

duration

d.malaria, defined as reported or measured (=

38?C) fever and positive rapid diagnostic test, or

4. Consent for study participation from parent or legal guardian

Exclusion Criteria

1.Severe acute malnutrition (WLZ < -3 or MUAC <115mm or oedema of both feet)

2.General danger sign (lethargic/unconscious, convulsions, unable to drink, vomits everything)

3.Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness)

4.Persistent diarrhoea (=14d)

5.Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy

6.Require hospital admission

7. Well child attended clinic only for routine growth monitoring or immunization

8.Child receiving food supplements for moderate wasting

9.Treated for moderate wasting in the previous 3 months

10.Previously enrolled in the study

11. Child lives outside the study area

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Anthropometric recovery from moderate wasting at any point up to 12 weeks after enrolment. <br/ ><br>- Sustenance of anthropometric recovery at 24 weeks <br/ ><br>Timepoint: 1. weekly visit from enrollemnt to 12 weeks for recovery. <br/ ><br>2. once at 24 weeks post enrollment for sustenance.

Secondary Outcome Measures

Name	Time	Method
-Median time to recovery <br/ ><br>-Mean change in Mid-upper arm circumference (MUAC in mm) and Weight-for-length z-score (WLZ) from enrolment to 12 weeks. <br/ ><br>-Proportion of children achieving a change in WLZ greater equal to 0.5 from baseline at any point up to 12 weeks after enrolment <br/ ><br>-Mean change in WAZ and LAZ scores, from enrolment to 12 weeks <br/ ><br>-Change in skinfold thickness measurements from enrolment to 12 weeks. <br/ ><br>- Deterioration to SAM or death up to 12 weeks <br/ ><br>-All-cause mortality, from enrolment to 24 weeks. <br/ ><br>- Any hospitalisation (greater than 24h) from enrolment to 24 weeksTimepoint: 1. Between enrollment and recovery by weekly visitation till 12 weeks. <br/ ><br>2. End study visitation at 24 weeks.