PACTR202306789094184

Providing breastfeeding support after discharge from hospital in order to improve growth and development of malnourished infants recovering from a serious illness

Enhancing growth and development among malnourished infants recovering from a serious illness (IBAMI2)
Oxford University·Phase 2·Pan Africa Clinical Trials Registry·otherNot yet recruiting
Study focus
Intervention type
other
Sponsor & location
Primary sponsor
Oxford University
Funder
Wellcome Trust
Location
Kenya
Timeline & enrollment
Phase
Phase 2
Start date
Jan 01, 1900
End date
Jan 01, 1900
Summary

Globally, acute malnutrition affects 8.5 million infants under 6 months of age (u6m). These malnourished infants u6m are at elevated risk of death during admission, death after discharge from hospital and subsequent neurodevelopmental impairment. The 2020 national guidelines for integrated management of acute malnutrition for infants and children (IMAM) recommend that for hospitalised malnourished infants u6m the treatment should focus on re-establishing exclusive breastfeeding (EBF) with discharge when consistent weight gain of >20g/day is achieved on breastmilk alone. In Kilifi,a study to investigate the outcomes of effective guideline implementation, employed breastfeeding peer supporters to facilitate re-establishing exclusive breastfeeding among sick hospitalised malnourished infants u6m.The study achieved 81% infants exclusive breastfeeding by discharge with 67% attaining the WHO recommended growth velocity on breastmilk alone. However, when infants were followed up 6 weeks after discharge, the criteria for full nutritional recovery (WFL>2) were generally not met. Interviews with mothers, breastfeeding peer supporters (BFPS) and health workers at discharge and 4 weeks after discharge suggested that BFPS were central in enabling mothers to achieve exclusive breastfeeding but that mothers found it challenging to maintain exclusive breastfeeding at home after discharge without on-going support.This follow-on study will investigate the hypothesis that providing support during transition from hospital to home environment will help improve nutritional recovery among this vulnerable group of infants. The study will take part in two phases.Phase 1 will use participatory and qualitative approaches to develop and pilot test a post-discharge breast-feeding support intervention (BFSI). Phase 2 will involve a randomized control trial to measure the impact of the intervention on growth, EBF and neurodevelopmental outcomes of malnourished infants discharged from hospital following a serious illness.The primary outcome for the trial is growth (weight gain) assessed at age 6 months, with additional follow up at 9 and 12 months of age to assess mortality, morbidity and neurodevelopmental outcomes. The results of the study will inform efforts to improve post-discharge management of recovering malnourished vulnerable infants u6m

ICD-10 classifications
Endocrine, nutritional and metabolic diseasesPersonal history of endocrine, nutritional and metabolic diseasesOther postprocedural endocrine and metabolic disordersFamily history of other endocrine, nutritional and metabolic diseasesPostprocedural endocrine and metabolic disorders, not elsewhere classified
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202306789094184
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR202306789094184 through Pure Global AI's free database. This Phase 2 trial is sponsored by Oxford University and is currently Not yet recruiting. The study focuses on Nutritional, Metabolic, Endocrine.

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