Trial no.:
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PACTR202306789094184 |
Date of Approval:
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28/06/2023 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Providing breastfeeding support after discharge from hospital in order to improve growth and development of malnourished infants recovering from a serious illness |
Official scientific title |
Enhancing growth and development among malnourished infants recovering from a serious illness (IBAMI2) |
Brief summary describing the background
and objectives of the trial
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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 |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
IBAMI 2 |
Disease(s) or condition(s) being studied |
Nutritional, Metabolic, Endocrine |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Breastfeeding support |
Anticipated trial start date |
30/10/2023 |
Actual trial start date |
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Anticipated date of last follow up |
30/10/2026 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
250 |
Actual target sample size (number of participants) |
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Recruitment status |
Not yet recruiting |
Publication URL |
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