|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
9 January 2023 |
|
Main ID: |
ISRCTN12494235 |
|
Date of registration:
|
09/11/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Management of Acute Malnutrition in Infants aged <6 months: Improving the evidence underlying new WHO Malnutrition Guidelines
|
|
Scientific title:
|
Severe malnutrition in infants aged <6months – seasonal prevalence, outcomes and risk factors in Bangladesh: Repeat cross sectional surveys and a prospective cohort study |
|
Date of first enrolment:
|
29/03/2015 |
|
Target sample size:
|
1638 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN12494235 |
|
Study type:
|
Observational |
|
Study design:
|
Observational cross sectional survey and prospective follow-up cohort study (Other)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Bangladesh
|
England
|
Kenya
|
United Kingdom
|
United States of America
| | | |
|
Contacts
|
|
Name:
|
M Munirul
Islam |
|
Address:
|
Nutrition and Clinical Services Division
68 Shaheed Tajuddin Ahmed Sarani
Mohakhali
1212
Dhaka
Bangladesh |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Prevalence survey:
Infants<6 months old.
Prospective cohort study:
Group A:
4-8 weeks old of either sex as ‘severe acute malnourished infant’ who have defined by weight-for-length <-3 z-score and or with presence of bilateral pitting oedema.
Group B:
4-8 weeks old of either sex as not severely acute malnourished infant’ who have weight-for-length =-2 to <2 z-scores and absence of bilateral pitting oedema.
Exclusion criteria:
Prevalence survey:
>6 months old infants.
Prospective Follow-up Study:
Other than the mentioned inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Malnurishment
Nutritional, Metabolic, Endocrine
Malnurishment
|
|
Intervention(s)
|
This study had two components. The first component is an observational study (an initial cross sectional survey among 742 infants<6m) conducted in Barisal Sadar upzila during the post-harvest season and again the survey is repeated during the pre-harvest season. All infants <6 mo are eligible until the desired number of infants is surveyed.
The second component is a prospective follow-up of at least 62 infants with severe acute malnutrition (WLZ <-3 and or with bipedal pitting oedema) as ‘severely malnourished infant’ (Group A) and at least 62 infants who are not suffering from acute malnutrition (weight-for-length =-2 to <2 z-scores and absence of any grade of oedema) as ‘not severely malnourished infant’ (Group B). An added indicator would be mid upper arm circumference (MUAC), if this is found to be suitable and appropriate for defining malnutrition like the older children after the prevalence survey is over. These both group of infants were enrolled when they were 4-6 weeks old and were followed up until they became 6 months or completed 180 days old. All infants in Group A were referred to a facility which was equipped to treat the young infants suffering from severe acute malnutrition.
|
|
Primary Outcome(s)
|
Prevalence survey:
Prevalence rate of infants<6 months old suffering from acute malnutrition was measured by number of infants suffering from acute malnutrition among the infants considered for the surveys.
Prospective Follow-up component:
Proportion of infants in Group A still being as ‘severely acute malnourished’ and proportion of children in Group B has become ‘severely acute malnourished’ at the end of 6 mo of age (180 completed days).
|
|
Secondary Outcome(s)
|
Prevalence survey:
Secondary outcome variables were current feeding practices, mostly focusing on 24 hour recall.
Prospective cohort study:
1. Mortality is measured as the proportion of initially well control infants who developed SAM at 6 months age;
2. Weight for length is measured as the changes in and absolute values of weight-for-length z-score (WLZ), weight-for-age z-score (WAZ), and length-for-age z-score (LAZ).
|
|
Source(s) of Monetary Support
|
|
Margaret A. Cargill Foundation, USA.
|
|
Ethics review
|
Status:
Approval date:
Contact:
Institutional Review Board of the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 01/03/2015
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
18/11/2015 |
|
URL:
|
|
|
|