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Follow Up of Severely Malnourished Children (FUSAM)

A

Action Against Hunger

Status

Completed

Conditions

Severe Acute Malnutrition

Treatments

Other: NUT treatment
Other: NUTPSY treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02672982
ACFInternational

Details and patient eligibility

About

The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.

Full description

In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.

Enrollment

427 patients

Sex

All

Ages

6 to 23 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 6-23 months
  • 2 sexes
  • Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district
  • Weight-for-height (WH) <-3 Standard Deviation compared to the WHO reference and/or MUAC <115 mm
  • And / or nutritional oedema moderate (+ or + +)
  • And successful test of appetite
  • And no medical complications
  • New cases
  • Presence of mother / father or legal guardian aged > 18 years.
  • Understanding of the consent and information letter
  • Follow-up possible

Exclusion criteria

  • Age <6 months or> 24 months
  • Moderate Acute Malnutrition
  • Severe Acute Malnutrition complicated
  • Weight for height <-3 Standard Deviation compared to the WHO reference and / or MUAC <115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe).
  • Relapse or if already registered in the past two months;
  • Any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

427 participants in 2 patient groups

new combined NUTPSY treatment
Experimental group
Description:
2-month combined nutrition and psychosocial intervention
Treatment:
Other: NUTPSY treatment
standard NUT treatment
Active Comparator group
Description:
2-month of standard nutritional treatment only
Treatment:
Other: NUT treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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