INTERVENTIONS |
Intervention type
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Intervention name
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Dose
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Duration
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Intervention description
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Group size
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Nature of control
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Control Group |
Arm 1 |
The control group in this clinical trial (Arm 1: Standard-of-Care) receives the standard treatment protocol that serves as the reference point for evaluating the effectiveness of the experimental interventions. Specifically, participants in the control group receive the following interventions and care:
Ready-to-Use Therapeutic Food (RUTF): Participants in the control group are provided with RUTF, a specialized, nutrient-dense food designed for the treatment of severe acute malnutrition. They will receive RUTF until they achieve nutritional recovery.
Standard Care According to WHO Guidelines: In addition to RUTF, participants in the control group receive all standard care measures outlined in the World Health Organization (WHO) guidelines for the treatment of severe acute malnutrition. These guidelines encompass a range of medical, nutritional, and supportive measures to promote recovery and well-being.
The purpose of the control group is to establish a baseline against which the effectiveness of the experimental intervention arms (Arms 2, 3, 4, and 5) can be compared. By providing the standard-of-care treatment, researchers can assess whether any of the experimental interventions offer superior outcomes in terms of the primary outcome, which is a composite measure of death, hospitalization, or failed nutritional recovery by 24 weeks post-randomization. This control group will help us determine if the new interventions are more effective than the existing standard of care for severe acute malnutrition. |
12 weeks post-randomization |
The control group in this clinical trial, known as Arm 1, will receive the standard-of-care treatment for severe acute malnutrition (SAM). The intervention for the control group is as follows:
Control Group (Arm 1: Standard-of-Care):
Ready-to-Use Therapeutic Food (RUTF): Participants in the control group receive RUTF, which is a specialized, nutrient-dense food designed for the treatment of severe acute malnutrition. They are provided with RUTF until they achieve nutritional recovery.
Standard Care According to WHO Guidelines: In addition to RUTF, participants in the control group receive all standard care measures outlined in the World Health Organization (WHO) guidelines for the treatment of severe acute malnutrition. These guidelines encompass a range of medical, nutritional, and supportive measures to promote recovery and well-being. The specific details of standard care will include medical assessments, hydration management, and monitoring for any complications associated with severe malnutrition. |
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Active-Treatment of Control Group |
Experimental Group |
Arm 2 |
In Arm 2 of this clinical trial, participants receive an antimicrobial prophylaxis package consisting of azithromycin, isoniazid, and rifampicin for a duration of 12 weeks post-discharge. This intervention aims to prevent and treat intercurrent infections in children recovering from complicated severe acute malnutrition (SAM), with a focus on reducing the risk of death, hospitalization, or failed nutritional recovery. Azithromycin, a broad-spectrum antibiotic with immunomodulatory properties, is administered to clear subclinical infections and create a pathogen-free environment. Isoniazid is used for tuberculosis prevention, especially in high-risk cases, while rifampicin provides additional antibacterial coverage. The extended duration of antimicrobial therapy seeks to safeguard against infections during the vulnerable period following hospital discharge. This intervention is based on previous research, acknowledging the increased infection susceptibility of malnourished children, but also considers potential concerns related to drug resistance and cost-effectiveness in its evaluation to inform public health decision-making. |
The duration of the antimicrobial prophylaxis intervention in Arm 2 of the clinical trial is 12 weeks post-discharge. |
The antimicrobial prophylaxis intervention in Arm 2 of the clinical trial entails providing children recovering from complicated severe acute malnutrition (SAM) with a 12-week course of medications, including azithromycin, isoniazid, and rifampicin post-discharge. Azithromycin serves to clear subclinical infections, create a pathogen-free environment, and potentially mitigate the acute phase response, given its broad-spectrum antibiotic properties and immunomodulatory effects. Isoniazid is administered for tuberculosis prevention, especially in high-risk cases, while rifampicin offers additional antibacterial coverage and effectively treats small intestinal bacterial overgrowth. The intervention aims to reduce the risk of mortality, hospitalization, or failed nutritional recovery during the vulnerable post-discharge period. It is based on prior research indicating potential benefits but takes into account concerns regarding drug resistance and cost-effectiveness, which will be evaluated to inform public health decisions. |
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Experimental Group |
Arm 3 |
In Arm 3 of the clinical trial, children admitted with complicated severe acute malnutrition (SAM) who have transitioned from therapeutic milk feeds to Ready-to-Use Therapeutic Food (RUTF) will receive a variable duration of RUTF supplementation based on their individual response to treatment. Initially, RUTF will be provided for at least 2 weeks, with the supply continuing beyond this period if necessary. The intervention aims to support the child until they achieve nutritional recovery, characterized by specific criteria such as a weight-for-height Z-score >-2, mid-upper arm circumference (MUAC) >12.5cm, and the absence of edema since the last study visit. If a child has not met these criteria by week 12, they will be classified as having reached the primary outcome of "failed nutritional recovery," and RUTF will be continued for a maximum of 16 weeks. In cases of relapse after nutritional recovery, RUTF supplementation will be restarted. This flexible dosing approach ensures that each child's nutritional needs are addressed until they reach the defined recovery criteria. |
In Arm 3 of the clinical trial, the duration of Ready-to-Use Therapeutic Food (RUTF) supplementation can vary based on the individual response of each child. Initially, RUTF will be supplied for at least 2 weeks. However, the duration may extend beyond these initial 2 weeks, and the intervention will continue until the child achieves nutritional recovery. Nutritional recovery is defined as meeting specific criteria, including a weight-for-height Z-score >-2, mid-upper arm circumference (MUAC) >12.5cm, and being free of edema since the last study visit. If a child has not reached the criteria for nutritional recovery by week 12, they will be classified as having reached the primary outcome of "failed nutritional recovery," and RUTF will be continued for a maximum of 16 weeks. The duration of RUTF supplementation is therefore flexible and aims to support each child until they achieve and maintain nutritional recovery or address cases of relapse. |
In Arm 3 of the clinical trial, children recovering from complicated severe acute malnutrition (SAM) receive a specialized intervention known as Ready-to-Use Therapeutic Food (RUTF). The distinguishing feature of this arm is the use of a reformulated RUTF, which may have altered nutrient composition but is not expected to compromise safety. While specific dosing details are not provided, RUTF is supplied for at least 2 weeks initially, with the intervention duration varying based on individual response. The primary goal is to support these children until they achieve nutritional recovery, defined by specific criteria, while considering the unique metabolic conditions in SAM. This intervention seeks to address the nutritional needs of participants and enhance their recovery during the trial. |
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Experimental Group |
Arm 4 |
In Arm 4, which involves the psychosocial intervention, caregiver-child pairs receive weekly intervention visits at weeks 1, 3, and 5. These visits are designed to deliver weekly problem-solving therapy and behavior-change modules for a total duration of 6 weeks. The content and focus of these psychosocial sessions aim to support the psychosocial well-being of the participants. |
The total duration of all interventions in Arm 4, as well as in other arms, is 12 weeks. |
Specifically, caregiver-child pairs receive weekly intervention visits at weeks 1, 3, and 5. These visits are designed to deliver problem-solving therapy and behavior-change modules over this 6-week period to support the psychosocial well-being of the participants. It's important to note that this is the duration of the psychosocial component of the intervention within Arm 4. Additionally, there are standard intervention visits for all arms at weeks 2, 4, 6, 8, and 12 post-randomization, which include other aspects of the intervention such as the resupply of Ready-to-Use Therapeutic Food (RUTF) |
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Experimental Group |
Arm 5 |
According to intervention Arm |
The total intervention duration for all arms is 12 weeks. |
In the combined arm, Arm 5, all of the interventions from Arms 2 (Antimicrobial package), 3 (Reformulated RUTF), and 4 (Psychosocial package) are given together. This means that participants in the combined arm receive a combination of the antimicrobial package, the reformulated RUTF, and the psychosocial intervention as part of their treatment. The combined arm is designed to assess the impact of these three interventions when administered together and evaluate whether the combination is more effective than the standard of care. The dosing and frequency of these interventions are typically specified in the trial protocol or related documents. |
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