Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2017
Date assigned
09/11/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute malnutrition is a major global public health problem causing over one million child deaths each year. Malnutrition is a serious condition that occurs when someone does not get the right amount of nutrients, leading to weight loss and other helath issues. Over the last decade, treatment of acute malnutrition in children aged 6-59 month has been revolutionized by a public health-orientated model of care, "Community-based Management of Acute Malnutrition" (CMAM). In contrast, acute malnutrition among infants aged under 6 months (infants<6m) remains relatively neglected. This has been partially addressed in the recently released 2013 World Health Organization Guideline on the Management of Severe Acute Malnutrition in Infants and Children. These guidelines however are based on low quality evidence. There is a need to improve the evidence base with data on assessment tools/criteria for infants less than 6 months old with acute malnutrition and effectiveness of the new guidelines, in their current form, for treating infants less than 6 months with acute malnutrition. The aim of this study is to provide critical background/baseline data towards future intervention trials exploring improved effectiveness of treating infants less than 6 months with acute malnutrition.

Who can participate?
Part 1: Infants less than six months old. Part 2: Infants aged 4-8 weeks who are either severely or not severely malnourished.

What does the study involve?
This study contains two parts. The first part is a survey of all infants aged six months and under conducted post-harvest and pre harvest season to measure the amount of infants suffering from malnutrition. The second part of the study is a follow up study. Participants will be chosen as those who were either not suffering from acute malnutrition and those who were severely malnourished. Participants are enrolled when they are 4-8 weeks old and followed up until they become six months or for 180 days. They are surveyed to see how malnourished they are and are measured for their weight, length and body measurements.

What are the possible benefits and risks of participating?
There may be advantages by taking part in research activities. The advantage of getting involved in this study is that it may be possible to determine the causes of children’s malnutrition (if present) and to guide the mother/caregiver appropriately as to where to seek treatment for malnutrition. Sometimes some studies may cause harm to the subject or make feeling of discomfort. The risk of this study is that, the mother may feel uncomfortable to answer some portion of the Self Reported Questionnaire (SRQ20) and Quality of Life (QOL) questionnaire. While measuring the length, mid-upper-arm-circumference and body weight of the child, s/he may feel uncomfortable, but these are not harmful for the child. The same procedures for measuring the child are common and have been used in previous research studies.

Where is the study run from?
This study is being run by Save the Children (USA) and takes place in Bangladesh.

When is the study starting and how long is it expected to run for?
September 2014-November 2015

Who is funding the study?
Margaret A. Cargill Foundation (USA)

Who is the main contact?
Dr M Munirul Islam
Ms Nichola Connell

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Munirul Islam

ORCID ID

Contact details

Nutrition and Clinical Services Division
68 Shaheed Tajuddin Ahmed Sarani
Mohakhali
Dhaka
1212
Bangladesh

Type

Scientific

Additional contact

Ms Nichola Connell

ORCID ID

Contact details

899 North Capitol Street NE
Suite 900
Washington DC
20002
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR-14112

Study information

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

Acronym

Study hypothesis

This is a prevalence survey to estimate the prevalence rate of infants<6 months old suffering from acute malnutrition. It includes a prospective follow-up component: To estimate the proportions 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).

Ethics approval

Institutional Review Board of the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 01/03/2015

Study design

Observational cross sectional survey and prospective follow-up cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malnurishment

Intervention

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.

Intervention type

Phase

Drug names

Primary outcome measure

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 measures

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).

Overall trial start date

01/09/2014

Overall trial end date

18/11/2015

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

Prevalence survey: 742 (post-harvest survey) and another 742 (pre-harvest survey); Prospective cohort study: 77 in each group.

Participant exclusion criteria

Prevalence survey:
>6 months old infants.

Prospective Follow-up Study:
Other than the mentioned inclusion criteria

Recruitment start date

29/03/2015

Recruitment end date

19/10/2015

Locations

Countries of recruitment

Bangladesh

Trial participating centre

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka
1212
Bangladesh

Trial participating centre

Save the Children Bangladesh
Dhaka
1212
Bangladesh

Trial participating centre

Save the Children USA
Washington DC
20002
United States of America

Trial participating centre

Emergency Nutrition Network
OX4 1TW
United Kingdom

Trial participating centre

London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom

Trial participating centre

KEMRI/Wellcome Trust Research Programme
43640-00100
Kenya

Sponsor information

Organisation

Department of Global Health, Save the Children USA

Sponsor details

899 North Capitol Street NE
Suite 900
Washington
DC
20002
United States of America

Sponsor type

Other

Website

Funders

Funder type

Charity

Funder name

Margaret A. Cargill Foundation, USA.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. Study protocol will be available upon request along with data analysis plan.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes