Stool frequency in Severe Acute Malnutrition

• Register: ISRCTN
• Last refreshed on: 20 November 2017
• Main ID: ISRCTN11571116
• Date of registration: 15/01/2014
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children (Canada)
• Public title: Stool frequency in Severe Acute Malnutrition
• Scientific title: Stool frequency in Severe Acute Malnutrition: a randomized controlled trial comparing maternal stool recall versus a direct stool observation method using diapers
• Date of first enrolment: 12/10/2013
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11571116
• Study type: Interventional
• Study design: Randomized gold-standard controlled interventional single-centre trial (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Malawi

Contacts

• Name: Wieger Voskuijl

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe acute malnutrition in children
Nutritional, Metabolic, Endocrine
Malnutrition

Intervention(s)

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

Primary Outcome(s)

1. Observed stool frequency
2. Stool consistency 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(s)

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).

Secondary ID(s)

N/A

Source(s) of Monetary Support

SickKids Foundation (Canada)