Simplified Treatment Protocol for Acute Malnutrition in Venezuela
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| ClinicalTrials.gov Identifier: NCT05543759 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2022
Last Update Posted : September 16, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Acute Malnutrition in Childhood Wasting Child Malnutrition | Dietary Supplement: Ready-To-Use Therapeutic Food (RUTF) |
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] |
| Estimated Enrollment : | 310 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela |
| Actual Study Start Date : | September 5, 2022 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | September 2023 |
| Group/Cohort | Intervention/treatment |
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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.
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Dietary Supplement: Ready-To-Use Therapeutic Food (RUTF)
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- 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
- 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
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| Ages Eligible for Study: | 6 Months to 59 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05543759
| Contact: Zulay Gonzalez, MSc | +584165181115 | zgonzalez@unicef.org | |
| Contact: Pablo Hernandez, MSc | +584124819733 | doctuscumliber@gmail.com |
| Venezuela | |
| Distrito Capital, La Guaira, Miranda | Recruiting |
| Caracas, Distrito Capital, Venezuela, 1060 | |
| Contact: Zulay Gonzalez, MSc +584165181115 zgonzalez@unicef.org | |
| Contact: Pablo Hernandez, MSc +584124819733 doctuscumliber@gmail.com | |
| Principal Investigator: | Zulay Gonzalez, MSc | UNICEF - Venezuela |
| Responsible Party: | UNICEF - Venezuela |
| ClinicalTrials.gov Identifier: | NCT05543759 |
| Other Study ID Numbers: |
291021 |
| First Posted: | September 16, 2022 Key Record Dates |
| Last Update Posted: | September 16, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Severe acute malnutrition Moderate acute malnutrition Ready-to-use therapeutic food Malnutrition treatment |
Venezuela Mid-upper arm circumference Wasting |
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Malnutrition Wasting Syndrome Child Nutrition Disorders Cachexia Nutrition Disorders |
Emaciation Weight Loss Body Weight Changes Body Weight Metabolic Diseases |