Simplified Treatment Protocol for Acute Malnutrition in Venezuela

NCT05543759 | Terminated

• 1 other identifier: 291021
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Longitudinal prevalence of wasting

  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

• Prevalence of child stunting

  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

• Prevalence of child morbidity

  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

• Prevalence of readmission

  Up to 6 months, at 24 weeks after the admission

Study Arms (1)

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.

Dietary Supplement: Ready-To-Use Therapeutic Food (RUTF)

Interventions

Ready-To-Use Therapeutic Food (RUTF) 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).

Cases

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICEF - Venezuela: lead

Study Sites (1)

Distrito Capital, La Guaira, Miranda

Caracas, Distrito Federal, 1060, Venezuela

Location

MeSH Terms

Conditions

Cachexia; Child Nutrition Disorders; Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition

Study Officials

• Zulay Gonzalez, MSc

  UNICEF - Venezuela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 5, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)