Simplified Treatment Protocol for Acute Malnutrition in Venezuela

• ClinicalTrials.gov Identifier: NCT05543759
• Recruitment Status: Recruiting
• First Posted: September 16, 2022
• Last Update Posted: September 16, 2022
• Sponsor: UNICEF - Venezuela
• Information provided by (Responsible Party): UNICEF - Venezuela

Tracking Information

• First Submitted Date: September 13, 2022
• First Posted Date: September 16, 2022
• Last Update Posted Date: September 16, 2022
• Actual Study Start Date: September 5, 2022
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2022)

• Recovery rate [ Time Frame: 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 ]
  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.
• Weight gain [ Time Frame: 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 ]
  Average weight change per month
• MUAC gain [ Time Frame: 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 ]
  Average change in MUAC per month
• Duration of the treatment [ Time Frame: 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 ]
  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
• Prevalence of relapse after discharge from the treatment [ Time Frame: at six months after the admission ]
  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
• Number of RUTF delivered per child [ Time Frame: 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 ]
  Average number of RUTF delivered per child (SAM/MAM)
• Cost per child [ Time Frame: 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 ]
  Average number of dollars that cost to recovery a child

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2022)

• Longitudinal prevalence of wasting [ Time Frame: 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 ]
  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.
• Prevalence of child stunting [ Time Frame: 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 ]
  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
• Prevalence of child morbidity [ Time Frame: 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 ]
  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
• Prevalence of readmission [ Time Frame: Up to 6 months, at 24 weeks after the admission ]
  Prevalence of children readmitted to the treatment within six months after after the admission

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Simplified Treatment Protocol for Acute Malnutrition in Venezuela
• Official Title: Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Biospecimen: Not Provided
• 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.

Condition

• Acute Malnutrition in Childhood
• Wasting
• Child Malnutrition

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).

Study Groups/Cohorts

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.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2022): 310
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 59 Months (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Zulay Gonzalez, MSc; +584165181115; zgonzalez@unicef.org

Contact: Pablo Hernandez, MSc; +584124819733; doctuscumliber@gmail.com

• Listed Location Countries: Venezuela

Administrative Information

• NCT Number: NCT05543759
• Other Study ID Numbers: 291021
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: UNICEF - Venezuela
• Original Responsible Party: Same as current
• Current Study Sponsor: UNICEF - Venezuela
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Zulay Gonzalez, MSc; UNICEF - Venezuela

• PRS Account: UNICEF - Venezuela
• Verification Date: September 2022