A community based study on locally prepared food for treating severe malnourished children of 6-59 months

Use of Energy Dense Food (EDF)/ Locally prepared therapeutic food for community based management in children aged 6- 59 months with Severe Acute Malnutrition - SAM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061109

Enrollment

200

Registered

2024-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Balamrutham +: Duration of intervention will be 16 weeks. Follow-up will be done every fortnightly and endline assessment at the end of 17th week. Control Intervention1: Ready to Use Th

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 6 - 59 months with Severe Acute Malnutrition based on following criteria: a) Weight for length/height z-score (WHZ) b) No Bilateral pitting oedema and no medical complication 2. Children whose families were likely to remain in the study area over the next 4-5 months, and residing in the same at least for the past six months. 3. Children with Severe Acute Malnutrition passing appetite test. 4. Children with above criteria and parent gives informed consent to participate.

Exclusion criteria

Exclusion criteria: 1. Children with Severe Acute Malnutrition and having any acute medical complications (they will be referred to facility based care for initial management / stabilization). 2. Bilateral pitting oedema of any grade. 3. Children where parent rejects to participate. 4. Children with severe illness requiring hospitalisation, haemoglobin 5. Children with congenital anomalies, cerebral palsy, neurogenerative disorders. 6. Children’s who do not have living parents. 7. Children with Co-morbid illness or systemic diseases, malabsorption, irritable bowel syndrome or celiac diseases, chronic diarrhea and chronic infections (HIV, Tuberculosis). 8. Children who have undergone any major surgery in last 6 months.

Design outcomes

Primary

Measure	Time frame
1. Weight gain: change in g/kg/day between baseline and recovery or 16 weeks of intervention, whichever will be earlier. We will also document the change in weight standard deviation scores from baseline and at different time points of follow up. 2. Recovery/ Discharged/ Cured: WHZ = -2 SD of the WHO standards and absence of oedema of feet at the end of 16-week follow-up 3. Relapse: children hospitalized or develop medical complication at any stage that requires admission (transferred out) and lost to follow-up over 16 weeks of intervention 4. Non responder: Cases who do not meet discharge criteria after 16 weeksTimepoint: 16 weeks	—

Measure

Time frame

1. Weight gain: change in g/kg/day between baseline and recovery or 16 weeks of intervention, whichever will be earlier. We will also document the change in weight standard deviation scores from baseline and at different time points of follow up. 2. Recovery/ Discharged/ Cured: WHZ = -2 SD of the WHO standards and absence of oedema of feet at the end of 16-week follow-up 3. Relapse: children hospitalized or develop medical complication at any stage that requires admission (transferred out) and lost to follow-up over 16 weeks of intervention 4. Non responder: Cases who do not meet discharge criteria after 16 weeksTimepoint: 16 weeks

—

Secondary

Measure	Time frame
1. Mortality rate 2. Height gain 3. Hemoglobin status 4. Adverse outcomes of other illness: occurrence of diarrhoea/ fever, RTI etc measured at any time during the 16 weeks of intervention 5. Acceptability of RUTF/ B+ 6. Adherence to treatment Timepoint: 16 week	—

Countries

India

Contacts

Public ContactKashish Vohra

All India Institute of Medical Sciences, AIIMS, New Delhi

dr.kapilyadav@gmail.com9818420553

Outcome results