Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/11/2013
Date assigned
15/01/2014
Last edited
15/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many young children in developing countries die because of malnutrition. If the children are admitted to hospital with severe acute malnutrition, the likelihood of dying is higher if they also suffer from diarrhea. It has been noticed that the mothers of many children might not always give an accurate report of the child's stool frequency and consistency. In order to provide good treatment an accurate report is very important. This study will compare what the mothers say about their children's defecation habits to what the healthcare workers are able to observe with the help of diapers. Our aim is to determine whether stool output as assessed by the maternal/carer recall method is same as when assessed using directly observed diapers in children with severe acute malnutrition.

Who can participate?
All children admitted to the Nutritional Rehabilitation Center of the Queen Elisabeth Central Hospital in Blantyre, Malawi, will be asked to participate in this study.

What does the study involve?
Children will be randomly allocated to either the control group, where the mothers will be asked about the stool habits of their child, or to the intervention group, where the healthcare professionals will assess the stool habits using diapers.

What are the possible benefits and risks of participating?
Since healthcare professionals conduct a thorough health check with every child admitted, children are under excellent supervision and receive the best care possible. It is also beneficial for the mothers of the sick children, since they are in close contact with the professionals, which gives them ample of opportunity to ask questions and be reassured that their child is taken care of. There are no risks associated with using diapers in children.

Where is the study run from?
Nutritional Rehabilitation Center of the Queen Elisabeth Central Hospital in Blantyre, Malawi.

When is the study starting and how long is it expected to run for?
The study will start in October 2013 and run until January 2014.

Who is funding the study?
The study will be funded by the SickKids Foundation, Toronto, Canada.

Who is the main contact?
Dr Wieger Voskuijl, MD, PhD

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wieger Voskuijl

ORCID ID

Contact details

Queen Elisabeth Central Hospital
Department of Paediatrics
Private Bag 360
Ginney Corner
Blantyre
-
Malawi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Stool frequency in Severe Acute Malnutrition: a randomized controlled trial comparing maternal stool recall versus a direct stool observation method using diapers

Acronym

StoolSAM

Study hypothesis

We hypothesize that stool output as assessed by the maternal/carer recall method is equivalent to a clinical gold-standard assessment using directly observed diapers in children with severe acute malnutrition (SAM).

Ethics approval

College of Medicine Research Ethics Committee, University of Malawi, 11/10/2013, P.07/13/1429

Study design

Randomized gold-standard controlled interventional single-centred trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Severe acute malnutrition in children

Intervention

1. Intervention group: conventional disposable diapers will be put on children and will be checked and changed every two hours by healthcare professionals. Mothers can also request to get the diapers changed within the 2 hours if there was a stool episode.
2. Control group: no intervention

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Observed stool frequency
2. Stool consistency in both groups is measured with the help of the Bristol stool chart and the Amsterdam paediatric stool chart (watery/loose/normal/bloody)

In the diaper group, diapers will be checked every two hours over a time period of 3 days. The day starts at 8.00 AM, from then on diapers will be checked at 10.00, 12.00, 14.00, 16.00 and 18.00. During the night (between 18.00 and 8.00), the night nurses are instructed to change the diapers whenever necessary (i.e., when there was an episode of stool) and collect those diapers in a bucket. In the control group, mothers are asked every morning during ward rounds (at around 10.00) about the stool episodes during the previous day with the help of a picture chart ('from sunrise to sunset = yesterday', 'from sunset to sunrise = last night', 'since sunrise').

Secondary outcome measures

The mother's opinion on the preferred stool assessment method (disposable diapers or no diapers). This will be assessed after completion of the study, i.e. on the morning after day 3. We are using a scale from 1-5 (1 = strongly prefer diapers, 5 = strongly prefer verbal recall method).

Overall trial start date

12/10/2013

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All children admitted to the Nutritional Rehabilitation Unit of the Queen Elisabeth Central Hospital in Blantyre, Malawi (MOYO) aged 6-40 months who meet the WHO and Malawi National Guidelines criteria for severe acute malnutrition (SAM) will be eligible to participate in this study:
1. Marasmus = weight-for-height less than or equal to -3 Z-scores (WHO growth standards) OR a mid-upper-arm circumference of <11.5 cm
2. Kwashiorkor = nutritionally induced bilateral pitting edema

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Children who are already potty trained and therefore do not require diapers
2. Circulatory and respiratory instability as assessed by the consulting physician
3. Severe rash in the genital area

Recruitment start date

12/10/2013

Recruitment end date

31/01/2014

Locations

Countries of recruitment

Malawi

Trial participating centre

Queen Elisabeth Central Hospital
Blantyre
-
Malawi

Sponsor information

Organisation

The Hospital for Sick Children (Canada)

Sponsor details

c/o Robert Bandsma
555 University Avenue
Toronto
M5G 1X8
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.sickkids.ca/

Funders

Funder type

Charity

Funder name

SickKids Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes