Clinical trial NCT06372418: Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants
Official title: Enhancing Growth and Development Among Malnourished Infants Recovering From a Serious Illness (IBAMI-2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition, Infant
Breastfeeding, Exclusive
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial:

Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants.

Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital.

Detailed description: 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 hospitalized malnourished infants u6m.The study achieved 81% infants exclusive breastfeeding by discharge with 67% attaining the World health organization recommended growth velocity on breastmilk alone. However, when infants were followed up 6 weeks after discharge, the criteria for full nutritional recovery, weight adjusted for Length Z score (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. Phase1 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.

Eligibility criteria: Inclusion Criteria:

Infants admitted to Kilifi County Hospital (KCH) aged between 4 weeks and 12 weeks old

AND Wasting or underweight assessed by Weight-for-length Z-score (WFLz)\<-2 OR Weight-for-age Z-score (WFAz) \<-2

OR Mid upper arm circumference (MUAC)\<110mm OR presence of bilateral pitting oedema 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.

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Primary outcomes:
measure: Weight gain
timeFrame: At 26 weeks of age
Secondary outcomes:
measure: Morbidity
timeFrame: At 39 weeks and 52 weeks of age
measure: Mortality
timeFrame: At 39 to 52 weeks of age
Other outcomes:
Locations:
Study officials:
affiliation: KEMRI WELLCOME TRUST
name: Martha Mwangome, PhD
role: PRINCIPAL_INVESTIGATOR
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