Malnutrition Nutritional, Metabolic, Endocrine
Conditions
Interventions
Clusters are community-based health centres and their catchment populations of small and nutritionally at-risk infants aged under 6 months (u6m).
The MAMI Care Pathway is a newly deve
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will enroll small and nutritionally at-risk infants aged under 5 months*, as defined by meeting at least one of the following characteristics: 1. Low weight-for-age Z-score 91st centile) 7. Infant feeding problem as reported by mother and confirmed by a healthcare worker 8. Maternal risk (mental health problem or other issue resulting in caring/feeding difficulty) A-priori main subgroup analysis will focus on infants with low WAZ (<-2 Z-scores) who will be expected to benefit most from the intervention. This main subgroup (for whom the trial is powered) will also: 9. Be recruited <4 months age 10. Not have an underlying disability or chronic illness 11. Not be orphans or have vulnerable mothers (severe mental health issues, social isolation, adolescent mother) 12. Be from singleton pregnancies *NB Though our target population for future programmes are all infants aged <6 months, the RCT will only recruit those aged <5 months since less than a month in the programme is too short a time for observable impact on our primary and secondary outcomes.
Exclusion criteria
Exclusion criteria: 1. Infants with ‘complicated malnutrition’: Those needing initial inpatient care as defined by standard clinical IMCI ‘danger signs’ (unable to breastfeed/drink, vomits everything, severe diarrhoea, severe fever, severe cough/respiratory distress, severe pallor) or other clinical problems needing immediate inpatient care. Though excluded at this point in time, these infants, once stabilized and improved following inpatient care are likely to return to clinics for future immunization, growth monitoring or other visits and may be screened again at those future visits. If still small/nutritionally vulnerable (but ‘uncomplicated’ clinically), it is possible that these may be recruited at future visits. 2. Infants with oedema, be that nutritional or non-nutritional This is also part of the definition of ‘complicated’ malnutrition and requires initial inpatient care to determine the cause and offer appropriate treatment). As with infants with other forms of complicated malnutrition, they might be recruited at future visits if their oedema has resolved but they meet other inclusion criteria. 3. Infants older than age 5 months, since: 3.1. A month in the programme is insufficient time to observe the benefit of the intervention 3.2. There would be a cohort effect whereby these older infants would be overrepresented in the RCT and would lead to non-generalizable results. This is because future MAMI programmes would be tracking infants at multiple points from birth onwards. Any with problems would very likely be recruited and supported in the early months of infancy. In contrast, because our RCT runs over a very short time period, the study would otherwise capture older infants who have never had the opportunity to be recruited/supported earlier. 4. Infant-mother dyads where a mother is unwilling or unable to commit to follow-up over the study time period (e.g., non-residents, individuals in transit, severe illness in mother). These non-eligible infants/mothers will receive care according to standard national and local guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight-for-age measured using Z-scores (WHO Growth Standards) at ages 6, 12,18 and 24 months old | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infant growth-related outcomes: 1.1. Stunting measured using the mean length-for-age 1.2. Wasting measured using the percentage weight-for-length <-2 or % mid-upper arm circumference <125 mm 2. Infant feeding outcome: 2.1. Breastfeeding measured according to standard WHO IYCF indicators 3. Infant clinical outcomes: 3.1. Recent morbidity measured from reported illness episodes in days of fever/diarrhoea/cough/other over the past 2 weeks 3.2. Clinically significant illness episodes measured as those resulting in an unscheduled clinic visit and/or inpatient admission 4. Maternal outcomes: 4.1. Maternal mental health measured using the PHQ-9 questionnaire 4.2. Maternal Quality of Life measured using the WHO short questionnaire The main project report will focus on outcomes at 6 months of age, but there will also be longer-term follow-ups at ages 12,18 and 24 months | — |
Countries
Ethiopia
Contacts
Public ContactMarko Kerac
Outcome results
None listed