Providing breastfeeding support after discharge from hospital in order to improve growth and development of malnourished infants recovering from a serious illness
Phase 2
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202306789094184
- Lead Sponsor
- Oxford University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
• Infants admitted to KCH aged between 4 weeks and 12 weeks old
AND
Wasting or underweight assessed by WFLz<-2 OR WFAz<-2 OR MUAC<110mm OR presence of bilateral pitting oedema(9)
AND
• Any possibility to breastfeed (carer of reproductive age willing to breastfeed and infant without clinical abnormalities obstructing breastfeeding
• Caregivers consent to participation in the study
Exclusion Criteria
• Infants with no possibility to breastfeed
OR
• Infants with congenital abnormalities that would affect breastfeeding e.g. cleft palate or invalidate the use of normal growth standards.
OR
• Infants whose caregivers refuse to consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome for the trial is growth (weight gain) assessed at age 6 months
- Secondary Outcome Measures
Name Time Method Secondary outcome will be assessed at 9 and 12 months of age to assess mortality, morbidity and neurodevelopmental outcomes.