Simplified Treatment Protocol for Acute Malnutrition in Venezuela

NCT ID: NCT05543759

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 307 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2022-11-30

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.

Conditions

Acute Malnutrition in Childhood; Wasting; Child Malnutrition

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

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 below with no medical complications and disability, and whose caregiver has granted consent to participate.

Ready-To-Use Therapeutic Food (RUTF)

Intervention Type: DIETARY_SUPPLEMENT

• SAM [MUAC <115mm or WHZ <-3 or oedema (+/++)] = Two 92g sachets RUTF/day (Approx. 1000 kcal/day).
• MAM [MUAC 115mm<125mm or WHZ <-2] = One 92g sachet RUTF/day (Approx. 500 kcal/day).

Interventions

Ready-To-Use Therapeutic Food (RUTF)

• SAM [MUAC <115mm or WHZ <-3 or oedema (+/++)] = Two 92g sachets RUTF/day (Approx. 1000 kcal/day).
• MAM [MUAC 115mm<125mm or WHZ <-2] = One 92g sachet RUTF/day (Approx. 500 kcal/day).

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICEF - Venezuela

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zulay Gonzalez, MSc

Role: PRINCIPAL_INVESTIGATOR

UNICEF - Venezuela

Locations

Distrito Capital, La Guaira, Miranda

Caracas, Distrito Federal, Venezuela

Countries

Venezuela

Other Identifiers

291021

Identifier Type: -

Identifier Source: org_study_id