An observational study in Acute Malnutrition in Childhood, Wasting and Child Malnutrition, sponsored by UNICEF - Venezuela. Terminated at 1 site in Venezuela. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by UNICEF - Venezuela · Observational
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.
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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's enrollment of 307 is above the median of 150 across 88 observational studies indexed under Cachexia.
Browse Cachexia studies →UNICEF - Venezuela is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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)
* 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).
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.
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
Weight gain
Average weight change per month
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
MUAC gain
Average change in MUAC per month
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
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
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
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
Time frame: at six months after the admission
Number of RUTF delivered per child
Average number of RUTF delivered per child (SAM/MAM)
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
Cost per child
Average number of dollars that cost to recovery a 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
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.
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
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
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
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
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
Prevalence of readmission
Prevalence of children readmitted to the treatment within six months after after the admission
Time frame: Up to 6 months, at 24 weeks after the admission
Plan to share: No
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Ran from Sep 2022 to primary completion in Nov 2022, 2 months.
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This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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UNICEF - Venezuela