Clinical trial NCT05543759: Simplified Treatment Protocol for Acute Malnutrition in Venezuela
Official title: Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Malnutrition in Childhood
Wasting
Child Malnutrition
Keywords: Severe acute malnutrition
Moderate acute malnutrition
Ready-to-use therapeutic food
Malnutrition treatment
Venezuela
Mid-upper arm circumference
Wasting
Lead sponsor: UNICEF - Venezuela
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 307
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible children are children aged 6-59 months of both sexes from households established permanently in the catchment area of the selected health posts or health centers, meeting the SAM or MAM acute malnutrition case definitions described above with no medical complications and disability, and whose caregiver has granted consent to participate.

Brief summary: Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ \<-2 or MUAC \<125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment and changes in anthropometry (weight, height and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.

Detailed description: The general objective of the study is to document the safety and effectiveness of Venezuelan simplified treatment protocol for Acute malnutrition of reduced frequency of follow-up visits, single product use and optimized daily RUTF dose.

This will be a prospective longitudinal study assessing the Venezuelan Simplified Combined Protocol among children with uncomplicated acute malnutrition according to the definition case study recently adopted by the Implementation Guidance: Prevention, Early Detection and Treatment of Wasting in Children 0-59 Months through National Health Systems in the Context of Coronavirus Disease, United Nations Children's Fund and World/Health Organization, for a single arm cohort included in treatment.

Children will be prospectively followed for a total of 6 months including the treatment phase and the immediate post-discharge weeks until 6 months.

An economic evaluation component will be incorporated. The economic valuation will be carried out based on quantitative data. Cost data will be collected from accounting records where available and through a series of interviews with key informants including health workers, civil society organizations, relevant staff from non-governmental organizations and United Nations agencies. Total costs will be aggregated and presented as cost per child treated and cost per child per child recovered.

The study will be implemented in 19 Community Health Centers purposively chosen based on their acute malnutrition prevalence and operational constraints. All of them will be proportionally distributed in three central states of Venezuela (Distrito Capital, Miranda, and La Guaira).

The protocol will be implemented by health professionals from each institution, duly previously trained in applying the study protocol.

Eligibility criteria: Inclusion Criteria:

* The child is between 6 and 23 months of age at inclusion.
* The mother must live in the study area from the time of inclusion.
* Mid-upper arm circumference (MUAC) \<12.5 cm or WHZ \<-2 or bilateral pitting edema.
* No serious medical complications.
* Positive appetite test.
* The consent of the mother or caregiver.

Exclusion Criteria:

* Congenital malformations that make anthropometric measurements impossible.
* Mother intends to leave the study area before six months.
* Presence of medical condition requiring referral for hospitalization.

Primary outcomes:
measure: Recovery rate
timeFrame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
measure: Weight gain
timeFrame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
measure: MUAC gain
timeFrame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
measure: Duration of the treatment
timeFrame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
measure: Prevalence of relapse after discharge from the treatment
timeFrame: at six months after the admission
measure: Number of RUTF delivered per child
timeFrame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
measure: Cost per child
timeFrame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Secondary outcomes:
measure: Longitudinal prevalence of wasting
timeFrame: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
measure: Prevalence of child stunting
timeFrame: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
measure: Prevalence of child morbidity
timeFrame: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
measure: Prevalence of readmission
timeFrame: Up to 6 months, at 24 weeks after the admission
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Distrito Capital, La Guaira, Miranda
state: Distrito Capital
Study officials:
affiliation: UNICEF - Venezuela
name: Zulay Gonzalez, MSc
role: PRINCIPAL_INVESTIGATOR
References: