Stool frequency in Severe Acute Malnutrition

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11571116

Enrollment

120

Registered

2014-01-15

Start date

2013-10-12

Completion date

Unknown

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute malnutrition in children Nutritional, Metabolic, Endocrine Malnutrition

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Secondary

Measure	Time frame
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).	—

Primary

Measure	Time frame
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').	—

Measure

Time frame

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').

—

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026