Severe Acute MalnutritionNCT05009823
Dietary Rehabilitation in Severely Acutely Malnourished Children
An observational study of Severe Acute Malnutrition and Kwashiorkor, run by University Ghent at 1 site in Burkina Faso.
Trial summary
Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 World Health Organization (WHO) growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the… Read more about this study
- Who is it for?
- Ages 0 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema
- What is being tested?
- Standard F75, Alternative F75 With CMV and Alternative F75 Without CMV
- How many people
- 1,959 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 10 Aug 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Eligible participants are children 0-59 Months of age who were hospitalized in the pediatric department for SAM with or without edema, and children hospitalized in other departments from CHUSS and received at CREN for treatment of SAM.
Who may be able to join
- Severe acute malnutrition defined as Weight-for-Height Z-score (WHZ) <- 3 SD AND / OR MUAC <115 mm AND / OR with edema
- With complications
- Who were admitted and treated in the refeeding center (CREN) of the CHUSS from January 2014 TO December 2018
- Aged between 0 and 59 Months
Who cannot join
- Older than 59 Months
- Moderate Acute Malnutrition (MAM)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso
Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 World Health Organization (WHO) growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. SAM results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children. Children with complicated SAM require inpatient treatment in specialized centers.
The "Rehabilitation and Nutritional Education Center" (CREN) is a specialized center in Burkina Faso receiving on average 10 SAM children per day. Recovery rate is lower than international standards; and adverse events and mortality remain strikingly high.
Read more
The main objective of this study is to assess the underlying risk factors affecting the effectiveness of the nutritional therapeutic treatment protocol for complicated SAM children under 5 years of age who have been referred to the CREN, at the Centre Hôspitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.
The specific objective of this study is to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively.
Read the detailed description
Severe acute malnutrition (SAM), defined as severe wasting [weight-to-height Z-score < -3 standard deviations (SD), based on the WHO Child Growth Standards] and / or the presence of nutritional edema, and / or mid-upper arm circumference (MUAC) <115 mm, is a condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. Management of SAM children without complications is provided at the community level. Hospitalization in specialized care centers is necessary for SAM children with complications. SAM children with comorbidities have a greater risk of mortality and treatment failure. The knowledge of the specific adequate nutritional needs of SAM is limited.
For the treatment of SAM in hospital, the WHO recommends the use of therapeutic milk low in protein 'F75' in the stabilization phase; and more protein-rich F100 or F75 combined with ready-to-use therapeutic foods (RUTF) in the transition phase. The WHO also recommends using as an alternative formula made of cereal flour, skimmed milk powder, oil, sugar, and a therapeutic vitamin and mineral complex (CMV), in case of shortage of the standard therapeutic milk F75 / F100 or in case of signs of intolerance (vomiting, diarrhea).
The Refeeding Center - Centre de Récupération et d'Education Nutritionnelle (CREN) of the Sourô Sanou University Hospital Center (CHUSS) in Burkina Faso specializes in the care of SAM children with complications. In 2018, out of 500 children aged 6-59 months admitted for SAM with complications, the CHUSS CREN registered 86.8% full recovery, 8.2% dropout and 5% death. Although the recovery rate is higher than international standards (greater than 75%), the mortality rate remains higher than the recommended 3% by international standards; in addition to the challenges that are faced locally in maintaining high standards of care. At the CREN, the investigators and the nurses observed that some SAM children with complications can have severe diarrhea and vomiting after taking F75 (first phase of the nutritional treatment). It was also observed that other SAM children with edema, whose edema resolved in the first phase of treatment under F75, redeveloped edema when they received RUTF (Plumpy Nut®) in the transition phase according to the WHO 2013 protocol.
This research project, which will be subdivided into a retrospective study and two prospective clinical trials aims to assess the risk factors affecting the response to dietary treatment in this center (the CREN, Burkina Faso) and to compare alternatives for treatment during the nutritional rehabilitation.
The retrospective study assesses the factors of failure of dietary treatment in the three phases of nutritional rehabilitation to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively and include:
- Errors in the treatment (feeding) dosage that can be due to errors in anthropometric measurement and/or in reading the feeding regimen table by the CREN team;
- Low adherence of children to the therapeutic dietary regimen
- Comorbidities associated with malnutrition that can have an effect on the dietary treatment effectiveness
- Types of dietary regimen selected during the first phase of treatment [F75 vs. alternative F75 (cereal flour, oil, sugar, powdered milk) with OR without CMV)] and during the transition phase [F75 + RUTF ( Plumpy-Nut®), F100, alternative F75 (with and without CMV) + RUTF (Plumpy Nut®)].
The study will use data collected during admission and follow-up of SAM children with complications admitted at the CREN of the CHUSS from January 2014 to December 2018.
- Conditions
- Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema, Marasmus
- Being tested
- Standard F75, Alternative F75 With CMV, Alternative F75 Without CMV, F100, Standard F75 + RUTF
- Keywords
- Severe acute malnutrition, Nutritional rehabilitation, F75, F100, Ready to use therapeutic food (RUTF), Stabilization phase, Transition phase, Kwashiorkor, Marasmus
- Medical subject headings
- Severe Acute Malnutrition, Kwashiorkor, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard F75Dietary supplement
F-75 contains 75 kcal and 0.9 g protein per 100 ml.
Alternative F75 With CMVDietary supplement
Cereal flour, oil, sugar, powdered milk with complex mineral-vitamin.
Alternative F75 Without CMVDietary supplement
Cereal flour, oil, sugar, powdered milk without complex mineral-vitamin.
F100Dietary supplement
100 kcal and 3 g protein per 100 ml if the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut)
Standard F75 + RUTFDietary supplement
Standard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive
Alternative F75 with CMV + RUTFDietary supplement
Alternative F75 + CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 + CMV during the stabilization phase
Alternative F75 without CMV + RUTFDietary supplement
Alternative F75 - CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 - CMV during the stabilization phase
| Study group | Role | What they receive |
|---|---|---|
| Stabilization phase | The dietetic treatment is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed.
A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis. Receives: Dietary Supplement: Standard F75; Dietary Supplement: Alternative F75 With CMV; Dietary Supplement: Alternative F75 Without CMV | |
| Transition phase | The child is assigned to one the therapeutic regimen depending on the treatment received during the stabilization phase and the results of the appetite test. Receives: Dietary Supplement: F100; Dietary Supplement: Standard F75 + RUTF; Dietary Supplement: Alternative F75 with CMV + RUTF; Dietary Supplement: Alternative F75 without CMV + RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days during the first phase of treatment
Average number of days spent in the stabilization phase in Days
Measured: Three to Seven days
Number of days during the transition phase of treatment
Average number of days spent in the transition phase in Days
Measured: Three to Five days
Daily weight gain during the first phase of treatment
Average daily weight gain in the stabilization phase in Grams
Measured: Three to Seven days
Daily weight gain during the transition phase
Average daily weight gain in the transition phase in Grams
Measured: Three to Five days
Edema redevelopment during the transition phase
Edema redevelopment during the transition phase after starting to resolve during the stabilizing phase.
Measured: Three to Five days
Secondary outcomes (5)
Anorexia
Serious severe event that occurs at anytime during the treatment
Measured: Through study completion, an average of 15 days
Mortality
Serious severe event that occurs at anytime during the treatment
Measured: Through study completion, an average of 15 days
Diarrhea
Serious severe event that occurs at anytime during the treatment
Measured: Through study completion, an average of 15 days
Vomiting
Serious severe event that occurs at anytime during the treatment
Measured: Through study completion, an average of 15 days
Adherence to the dietary treatment
Daily intake of the administered dietary treatment
Measured: Through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Aug 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,959 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso), Centre Muraz
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, Md. PhD, Principal investigator, University GhentSouheila Abbeddou, MSc. PhD, Principal investigator, University GhentJerome Some, Md. PhD, Principal investigator, Institut de Recherche en Sciences de la Sante, Burkina FasoBintou Sanogo, MSc. Md., Principal investigator, Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009823
- Sponsor's protocol ID
- BC-09443
- Status last verified
- Nov 2023
- First submitted
- 2 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary.
Publications
Baraki AG, Akalu TY, Wolde HF, Takele WW, Mamo WN, Derseh B, Desyibelew HD, Dadi AF. Time to recovery from severe acute malnutrition and its predictors: a multicentre retrospective follow-up study in Amhara region, north-west Ethiopia. BMJ Open. 2020 Feb 13;10(2):e034583. doi: 10.1136/bmjopen-2019-034583.
PubMed 32060161Bartz S, Mody A, Hornik C, Bain J, Muehlbauer M, Kiyimba T, Kiboneka E, Stevens R, Bartlett J, St Peter JV, Newgard CB, Freemark M. Severe acute malnutrition in childhood: hormonal and metabolic status at presentation, response to treatment, and predictors of mortality. J Clin Endocrinol Metab. 2014 Jun;99(6):2128-37. doi: 10.1210/jc.2013-4018. Epub 2014 Feb 27.
PubMed 24606092Deen JL, Funk M, Guevara VC, Saloojee H, Doe JY, Palmer A, Weber MW. Implementation of WHO guidelines on management of severe malnutrition in hospitals in Africa. Bull World Health Organ. 2003;81(4):237-43. Epub 2003 May 16.
PubMed 12764489Munthali T, Jacobs C, Sitali L, Dambe R, Michelo C. Mortality and morbidity patterns in under-five children with severe acute malnutrition (SAM) in Zambia: a five-year retrospective review of hospital-based records (2009-2013). Arch Public Health. 2015 May 1;73(1):23. doi: 10.1186/s13690-015-0072-1. eCollection 2015.
PubMed 25937927
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso
- ClinicalTrials.gov ID
- NCT05009823
- Acronym / sponsor ID
- BC-09443
- Conditions
- Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema, Marasmus
- Keywords
- Severe acute malnutrition, Nutritional rehabilitation, F75, F100, Ready to use therapeutic food (RUTF), Stabilization phase, Transition phase, Kwashiorkor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,959 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso), Centre Muraz
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 World Health Organization (WHO) growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. SAM results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children. Children with complicated SAM require inpatient treatment in specialized centers.
The "Rehabilitation and Nutritional Education Center" (CREN) is a specialized center in Burkina Faso receiving on average 10 SAM children per day. Recovery rate is lower than international standards; and adverse events and mortality remain strikingly high.
The main objective of this study is to assess the underlying risk factors affecting the effectiveness of the nutritional therapeutic treatment protocol for complicated SAM children under 5 years of age who have been referred to the CREN, at the Centre Hôspitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.
The specific objective of this study is to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively.
Detailed description
Severe acute malnutrition (SAM), defined as severe wasting [weight-to-height Z-score < -3 standard deviations (SD), based on the WHO Child Growth Standards] and / or the presence of nutritional edema, and / or mid-upper arm circumference (MUAC) <115 mm, is a condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. Management of SAM children without complications is provided at the community level. Hospitalization in specialized care centers is necessary for SAM children with complications. SAM children with comorbidities have a greater risk of mortality and treatment failure. The knowledge of the specific adequate nutritional needs of SAM is limited.
For the treatment of SAM in hospital, the WHO recommends the use of therapeutic milk low in protein 'F75' in the stabilization phase; and more protein-rich F100 or F75 combined with ready-to-use therapeutic foods (RUTF) in the transition phase. The WHO also recommends using as an alternative formula made of cereal flour, skimmed milk powder, oil, sugar, and a therapeutic vitamin and mineral complex (CMV), in case of shortage of the standard therapeutic milk F75 / F100 or in case of signs of intolerance (vomiting, diarrhea).
The Refeeding Center - Centre de Récupération et d'Education Nutritionnelle (CREN) of the Sourô Sanou University Hospital Center (CHUSS) in Burkina Faso specializes in the care of SAM children with complications. In 2018, out of 500 children aged 6-59 months admitted for SAM with complications, the CHUSS CREN registered 86.8% full recovery, 8.2% dropout and 5% death. Although the recovery rate is higher than international standards (greater than 75%), the mortality rate remains higher than the recommended 3% by international standards; in addition to the challenges that are faced locally in maintaining high standards of care. At the CREN, the investigators and the nurses observed that some SAM children with complications can have severe diarrhea and vomiting after taking F75 (first phase of the nutritional treatment). It was also observed that other SAM children with edema, whose edema resolved in the first phase of treatment under F75, redeveloped edema when they received RUTF (Plumpy Nut®) in the transition phase according to the WHO 2013 protocol.
This research project, which will be subdivided into a retrospective study and two prospective clinical trials aims to assess the risk factors affecting the response to dietary treatment in this center (the CREN, Burkina Faso) and to compare alternatives for treatment during the nutritional rehabilitation.
The retrospective study assesses the factors of failure of dietary treatment in the three phases of nutritional rehabilitation to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively and include:
- Errors in the treatment (feeding) dosage that can be due to errors in anthropometric measurement and/or in reading the feeding regimen table by the CREN team;
- Low adherence of children to the therapeutic dietary regimen
- Comorbidities associated with malnutrition that can have an effect on the dietary treatment effectiveness
- Types of dietary regimen selected during the first phase of treatment [F75 vs. alternative F75 (cereal flour, oil, sugar, powdered milk) with OR without CMV)] and during the transition phase [F75 + RUTF ( Plumpy-Nut®), F100, alternative F75 (with and without CMV) + RUTF (Plumpy Nut®)].
The study will use data collected during admission and follow-up of SAM children with complications admitted at the CREN of the CHUSS from January 2014 to December 2018.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization phase | – | Dietary Supplement: Standard F75, Dietary Supplement: Alternative F75 With CMV, Dietary Supplement: Alternative F75 Without CMVThe dietetic treatment is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis. |
| Transition phase | – | Dietary Supplement: F100, Dietary Supplement: Standard F75 + RUTF, Dietary Supplement: Alternative F75 with CMV + RUTF, Dietary Supplement: Alternative F75 without CMV + RUTFThe child is assigned to one the therapeutic regimen depending on the treatment received during the stabilization phase and the results of the appetite test. |
Who may qualify
- Ages
- 0 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible participants are children 0-59 Months of age who were hospitalized in the pediatric department for SAM with or without edema, and children hospitalized in other departments from CHUSS and received at CREN for treatment of SAM.
Key inclusion criteria (4 listed)
- Severe acute malnutrition defined as Weight-for-Height Z-score (WHZ) <- 3 SD AND / OR MUAC <115 mm AND / OR with edema
- With complications
- Who were admitted and treated in the refeeding center (CREN) of the CHUSS from January 2014 TO December 2018
- Aged between 0 and 59 Months
Key exclusion criteria (2 listed)
- Older than 59 Months
- Moderate Acute Malnutrition (MAM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard F75F-75 contains 75 kcal and 0.9 g protein per 100 ml. | Dietary supplement | Stabilization phase |
| Alternative F75 With CMVCereal flour, oil, sugar, powdered milk with complex mineral-vitamin. | Dietary supplement | Stabilization phase |
| Alternative F75 Without CMVCereal flour, oil, sugar, powdered milk without complex mineral-vitamin. | Dietary supplement | Stabilization phase |
| F100100 kcal and 3 g protein per 100 ml if the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut) | Dietary supplement | Transition phase |
| Standard F75 + RUTFStandard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive | Dietary supplement | Transition phase |
| Alternative F75 with CMV + RUTFAlternative F75 + CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 + CMV during the stabilization phase | Dietary supplement | Transition phase |
| Alternative F75 without CMV + RUTFAlternative F75 - CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 - CMV during the stabilization phase | Dietary supplement | Transition phase |
Primary outcome
Number of days during the first phase of treatment
Time frame: Three to Seven days
Average number of days spent in the stabilization phase in Days
Number of days during the transition phase of treatment
Time frame: Three to Five days
Average number of days spent in the transition phase in Days
Daily weight gain during the first phase of treatment
Time frame: Three to Seven days
Average daily weight gain in the stabilization phase in Grams
Daily weight gain during the transition phase
Time frame: Three to Five days
Average daily weight gain in the transition phase in Grams
Edema redevelopment during the transition phase
Time frame: Three to Five days
Edema redevelopment during the transition phase after starting to resolve during the stabilizing phase.
5 secondary outcomes
Anorexia
Time frame: Through study completion, an average of 15 days
Mortality
Time frame: Through study completion, an average of 15 days
Diarrhea
Time frame: Through study completion, an average of 15 days
Vomiting
Time frame: Through study completion, an average of 15 days
Adherence to the dietary treatment
Time frame: Through study completion, an average of 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 32060161Baraki AG, Akalu TY, Wolde HF, Takele WW, Mamo WN, Derseh B, Desyibelew HD, Dadi AF. Time to recovery from severe acute malnutrition and its predictors: a multicentre retrospective follow-up study in Amhara region, north-west Ethiopia. BMJ Open. 2020 Feb 13;10(2):e034583. doi: 10.1136/bmjopen-2019-034583.
- Background: PubMed 24606092Bartz S, Mody A, Hornik C, Bain J, Muehlbauer M, Kiyimba T, Kiboneka E, Stevens R, Bartlett J, St Peter JV, Newgard CB, Freemark M. Severe acute malnutrition in childhood: hormonal and metabolic status at presentation, response to treatment, and predictors of mortality. J Clin Endocrinol Metab. 2014 Jun;99(6):2128-37. doi: 10.1210/jc.2013-4018. Epub 2014 Feb 27.
- Background: PubMed 12764489Deen JL, Funk M, Guevara VC, Saloojee H, Doe JY, Palmer A, Weber MW. Implementation of WHO guidelines on management of severe malnutrition in hospitals in Africa. Bull World Health Organ. 2003;81(4):237-43. Epub 2003 May 16.
- Background: PubMed 25937927Munthali T, Jacobs C, Sitali L, Dambe R, Michelo C. Mortality and morbidity patterns in under-five children with severe acute malnutrition (SAM) in Zambia: a five-year retrospective review of hospital-based records (2009-2013). Arch Public Health. 2015 May 1;73(1):23. doi: 10.1186/s13690-015-0072-1. eCollection 2015.
- World Health Organization (2013) WHO guideline: updates on the management of severe acute malnutrition in infants and children.Link provided by the sponsor.
- 10\. Ministère de la Sante au Burkina Faso. Protocol National : Prise en charge intégrée de la malnutrition aigüe (PCIMA). 2014Link provided by the sponsor.
- Individual participant dataSharing planned: No. All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefaan De Henauw, Md. PhD principal investigator
University Ghent
Souheila Abbeddou, MSc. PhD principal investigator
University Ghent
Jerome Some, Md. PhD principal investigator
Institut de Recherche en Sciences de la Sante, Burkina Faso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Malnutrition and Kwashiorkor, run by University Ghent at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days during the first phase of treatment (time frame: Three to Seven days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009823, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.