Modifying Intestinal integrity and MicroBiome in severe Malnutrition with LEgume-based feeds
- Conditions
- Nutritional, Metabolic, EndocrinePaediatricsMalnutrition
- Registration Number
- PACTR201805003381361
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
Anthropometric features of severe acute malnutrition as per WHO Child Growth Standards (2006):
1.Marasmus: Mid-upper arm circumference (MUAC) <11.5cm or Weight-for-height Z-score (WHZ) < -3
2.Kwashiorkor: Symmetrical pitting oedema involving at least the feet irrespective of WHZ score or MUAC
3.Guardian or parent willing and able to provide consent
Children with severe acute malnutrition with a very high risk of early death will be excluded:
¿Impaired consciousness: one of prostration (inability to sit unsupported or inability to breast feed if < 9months) or coma (inability to localise a painful stimulus) after correction of hypoglycaemia if present.
¿Shock: two or more of capillary refill time > 3s, lower limb temperature gradient or weak radial pulse volume.
¿Severe dehydration: Sunken eyes and reduced skin turgor in the presence of diarrhoea (3 or more episodes of profuse and watery stool)
¿Respiratory distress: increased work of breathing and hypoxia (oxygen saturation < 90% in air)
Additionally children who cannot complete accurate dietary recall will be excluded:
¿Exclusively breast-fed infants
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Co-primary outcome measures: 1.Weight gain (moderate to good: >5g/kg/day) 2.Survival to Day 28
- Secondary Outcome Measures
Name Time Method 1.Clinical outcome : a.Time to diarrhoea resolution (if >3 loose stools/day) b.Time to oedema resolution c.Time to return of appetite d. Time to nutritional rehabilitation