Severe Acute MalnutritionNCT04582773
Improving the Outcomes of Community-based Management of Acute Malnutrition
An observational study of Severe Acute Malnutrition, run by The Hospital for Sick Children at 1 site in Nigeria.
Trial summary
Severe acute malnutrition (SAM) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- How many people
- 1,087 participants
- Where
- 1 siteNigeria
- Study dates
- 22 Jul 2019to 30 Oct 2020
- 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 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Children between 1-59 months with severe acute malnutrition admitted into inpatient care within CMAM program run by the non-governmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
Who may be able to join
- Aged 1 to 59 months
- Diagnosed with severe acute malnutrition (criteria for severe acute malnutrition is <3Z Weight for Height Z score, and/or MUAC <115mm, and/or bilateral pitting oedema)
- Meet the criteria for admission into inpatient care (failed appetite test, and/or medical conditions).
- Study amendment for inclusion: children with and without severe acute malnutrition admitted to emergency pediatric unit (EPU)
Who cannot join
- Children with congenital anomalies that interfere with feeding (ie. cleft lip and/or palate); previous enrolment in this study.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
University of Maiduguri Teaching Hospital
Maiduguri, Borno State
About this study
Severe acute malnutrition (SAM) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. The current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. The purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment programs and thus improve child health outcomes.
Read the detailed description
A prospective observational study in inpatient care within community-based management of acute malnutrition(CMAM) program run by the nongovernmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
The objectives of the study are to validate the BedsidePEWS scores as a measure of severity of illness in children who are treated as inpatients for severe acute malnutrition and to compare the BedsidePEWS scores with other risk factors associated for mortality and relapse of children with severe acute malnutrition. The design is a prospective observational study of 1000 children admitted as inpatients in a CMAM program in Maidaguri Teaching Hospital in Maidaguri, Nigeria. Data collection (estimated duration 4-5 months) involves vital signs, and risk factor assessment every 12 hours for duration of hospitalization. Blood test for hemoglobin and malaria will be done once upon admission. Outcomes will be measured every 12 hours and include mortality and/or escalation and de-escalation of care. Logistic regression with significance testing will be used to compare BedsidePEWS scores and risk factors between patients and among individual patients within the outcome categories. Exploratory sensitivity analyses will repeat the main logistic regression analyses to evaluate the performance of partial BedsidePEWS score in patients with missing data of 1-3 of the 7 components, by randomly removing 1-3 data elements from the score calculation from patients, and by removing systolic blood pressure from scoring.
- Conditions
- Severe Acute Malnutrition
- Medical subject headings
- Severe Acute Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient mortality
survival or death during inpatient care
Measured: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Secondary outcomes (2)
Number of Children receiving inpatient care who required escalation of treatment
transfer from unit of lower to higher level of care within inpatient treatment
Measured: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Number of Children receiving inpatient care who required de-escalation of treatment
transfer from unit of higher to lower level of care within inpatient treatment
Measured: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start22 Jul 2019
- Primary completion25 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for International Medical Action, University of Maiduguri Teaching Hospital, Tampere University
- Responsible party
- Principal investigator, Christopher Parshuram, The Hospital for Sick Children
- Investigators
- Chris Parshuram, MD/PHD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582773
- Sponsor's protocol ID
- REB1000063224
- Status last verified
- Jan 2021
- First submitted
- 8 Sep 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Outcomes of Community-based Management of Acute Malnutrition
- ClinicalTrials.gov ID
- NCT04582773
- Acronym / sponsor ID
- REB1000063224
- Conditions
- Severe Acute Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,087 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Alliance for International Medical Action, University of Maiduguri Teaching Hospital, Tampere University
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 12 Oct 2020 (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) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. The current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. The purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment programs and thus improve child health outcomes.
Detailed description
A prospective observational study in inpatient care within community-based management of acute malnutrition(CMAM) program run by the nongovernmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
The objectives of the study are to validate the BedsidePEWS scores as a measure of severity of illness in children who are treated as inpatients for severe acute malnutrition and to compare the BedsidePEWS scores with other risk factors associated for mortality and relapse of children with severe acute malnutrition. The design is a prospective observational study of 1000 children admitted as inpatients in a CMAM program in Maidaguri Teaching Hospital in Maidaguri, Nigeria. Data collection (estimated duration 4-5 months) involves vital signs, and risk factor assessment every 12 hours for duration of hospitalization. Blood test for hemoglobin and malaria will be done once upon admission. Outcomes will be measured every 12 hours and include mortality and/or escalation and de-escalation of care. Logistic regression with significance testing will be used to compare BedsidePEWS scores and risk factors between patients and among individual patients within the outcome categories. Exploratory sensitivity analyses will repeat the main logistic regression analyses to evaluate the performance of partial BedsidePEWS score in patients with missing data of 1-3 of the 7 components, by randomly removing 1-3 data elements from the score calculation from patients, and by removing systolic blood pressure from scoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 1-59 months with severe acute malnutrition admitted into inpatient care within CMAM program run by the non-governmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
Key inclusion criteria (4 listed)
- Aged 1 to 59 months
- Diagnosed with severe acute malnutrition (criteria for severe acute malnutrition is <3Z Weight for Height Z score, and/or MUAC <115mm, and/or bilateral pitting oedema)
- Meet the criteria for admission into inpatient care (failed appetite test, and/or medical conditions).
- Study amendment for inclusion: children with and without severe acute malnutrition admitted to emergency pediatric unit (EPU)
Key exclusion criteria (1 listed)
- Children with congenital anomalies that interfere with feeding (ie. cleft lip and/or palate); previous enrolment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inpatient mortality
Time frame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
survival or death during inpatient care
2 secondary outcomes
Number of Children receiving inpatient care who required escalation of treatment
Time frame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Number of Children receiving inpatient care who required de-escalation of treatment
Time frame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
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 2 Feb 2021.
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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.
Chris Parshuram, MD/PHD principal investigator
The Hospital for Sick Children
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, run by The Hospital for Sick Children at 1 site in Nigeria.
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 1 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 2 Feb 2021. 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 Nigeria. 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?
Inpatient mortality (time frame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.