Simplified Treatment Protocol for Acute Malnutrition in Venezuela

Child Malnutrition Clinical Trial

Official title:

Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05543759
• Other study ID #: 291021
• Status: Terminated
• Start date: September 5, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2023
• Source: UNICEF - Venezuela
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 307
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition
• Wasting

Intervention

Dietary Supplement:
• 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).

Locations

Country	Name	City	State
Venezuela	Distrito Capital, La Guaira, Miranda	Caracas	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
UNICEF - Venezuela

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	This indicator is defined as the number children who recovered from wasting, MAM and SAM according to national program criteria (WHZ>-2 and MUAC>=125mm and absence of bilateral edema for two consecutive visits, within 16 weeks of enrollment in the program) divided by the total number of treatment results recorded.	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
Primary	Weight gain	Average weight change per month	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
Primary	MUAC gain	Average change in MUAC per month	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
Primary	Duration of the treatment	Defined as the average number of weeks spent on treatment (enrollment and discharge) in children 6-59 months of age at enrollment, according to health registers	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
Primary	Prevalence of relapse after discharge from the treatment	This indicator is defined as the proportion of children with WHZ-score <-2 or MUAC <125 mm or bilateral edema six months after the admission	at six months after the admission
Primary	Number of RUTF delivered per child	Average number of RUTF delivered per child (SAM/MAM)	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
Primary	Cost per child	Average number of dollars that cost to recovery a child	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	Longitudinal prevalence of wasting	This indicator is defined for each child as the number of visits during which nutritional wasting is observed divided by the total number of monthly visits made.	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
Secondary	Prevalence of child stunting	Proportion of children with Height-for-age Z-score (LAZ)<-2 (according to the 2006 World Health Organization reference) at the end of the study	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
Secondary	Prevalence of child morbidity	Defined by the number of days with symptoms of acute respiratory infections, fever, diarrhea (three or more loose or liquid stools per day) and malaria divided by the total number of days observed/reported in the recall period	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
Secondary	Prevalence of readmission	Prevalence of children readmitted to the treatment within six months after after the admission	Up to 6 months, at 24 weeks after the admission