Improved Breastfeeding Support to Treat Acute Malnutrition amongst Infants under 6 months (IBAMI)

For the first time, in 2013, the WHO guidelines for treating children with Severe Acute Malnutrition (SAM) included guidance on how to diagnose and treat SAM in infants aged below 6 months. The treatment guidelines for infants under 6 months focused on inpatient treatment and recommended that admitted infants with SAM be supported to re-establish exclusive breastfeeding before they can be discharged. The recommendation was based mainly on programmatic reports and a few studies that had shown that lactation failure is common among infants with SAM, and that re-establishing breastfeeding among infants being treated for SAM is possible using re-lactation techniques such as supplementary suckling. However, since none of the studies followed infants up after discharge, we still do not know i) if exclusive breastfeeding was retained after discharge; ii) if retaining exclusive breastfeeding after discharge is sufficient for nutritional recovery and iii) if additional breastfeeding support offered to mothers of discharged infants would be beneficial.

The proposed study is aimed at generating important information to develop a trial to establish the effectiveness of home-based breastfeeding support to mothers of infants discharged from SAM treatment on survival and growth.

The main aim of the proposed study is to i) establish the breastfeeding retention rate among infants under 6 months discharged from SAM treatment within the current strategies that are without a specific post discharge breastfeeding support; and ii) establish whether among infants retaining exclusive breastfeeding, breastmilk alone is sufficient for nutritional recovery. This information will form the baseline data from where any success of any applied intervention will be measured. Hence the findings from this study will strengthen the calculations of the sample size required to show an improvement in the outcomes due to an intervention.

In addition, the study will provide insight on the acceptability and sustainability of using peer breastfeeding supporters commonly used to encourage breastfeeding in preterm neonates for infants with SAM. It will also provide information on the optimal trial follow-up strategy that could be applied successfully for this group of participants.

Apart from providing information for trial development, the study findings will by themselves provide data to previously identified research gap. Within the 2013 updated WHO guidelines on management of SAM in children, http://apps.who.int/iris/bitstream/10665/95584/1/9789241506328_eng.pdf (page 66) the question of how breastfeeding is most effectively established is raised. Our study intends to optimize the WHO inpatient treatment guidelines and will in the process develop a step-by-step re-lactation protocol that would be applicable for resource poor settings. Recently, using the well developed and highly recommended Child Health and Nutrition Research Initiative (CHNRI) methodology, researchers, developmental partners and other stakeholders including UN agencies identified that research into the components of a package care for outpatient care as one of the top research priorities for infants with SAM (Angood, McGrath et al. 2015). Findings from the proposed study will provide baseline information useful in designing and testing a package for outpatient care.

Globally,4.7 million infants suffer from severe acute malnutrition (SAM). Recent data suggests that survival of these infants during and after admission is very poor. In a recently completed clinical trial (https://clinicaltrials.gov/ct2/show/NCT00934492) during 1 year follow up, mortality was 31 per 100 child years and weight gain was poor. Breastfeeding is the main thrust of the WHO treatment guidelines and hence interventions within this group are anchored on improving breastfeeding, however no studies have tested optimization of breastfeeding in this context, thus key questions still remain unanswered: is successful re-establishing exclusive breastfeeding during inpatient treatment maintained after discharge and result in nutritional recovery and survival?
We aim to draw from neonatal and infant feeding experiences to create a breastfeeding support package for mothers of infants discharged from SAM treatment that can be tested in a randomized clinical trial. However, in order to design the trial we need precise data on the proportion of infants achieving and retaining exclusive breastfeeding after discharge.
We proposed conducting a prospective cohort study involving 90 infants aged 4 weeks to 4 months admitted with SAM at the Kilifi County Hospital (KCH). Participants will be managed as per the WHO treatment guidelines and followed up at 1, 2, 4 and 8 weeks. Anthropometry, breastfeeding status, morbidity and mortality will be collected. Views on challenges and drivers of breastfeeding retention will also be collected, and a package of support designed.
The primary outcome is the proportion of infants under 6 months exclusively breastfeeding 4 weeks after discharge. The findings will provide baseline data on breastfeeding retention rate in the absence of an intervention. This data will directly inform sample size estimation and design for a clinical trial testing breastfeeding support packages for infants discharged from SAM treatment.

The project aims to lead to a clinical trial that will directly inform national actors (e.g. Ministries of Health) and international bodies such as UNICEF and WHO, who are responsible for updating guidelines and policies. The project will generate: i) data on the proportion of infants retaining exclusive breastfeeding after discharge from Severe Acute Malnutrition (SAM) treatment ; ii) knowledge on whether exclusive breastfeeding alone is sufficient for nutritional recovery of SAM infants; and iii) knowledge of the challenges and drivers for retaining breastfeeding after discharge.
Ultimately, the beneficiaries will be undernourished infants, who will receive the updated WHO recommended treatment which are currently not applied in rural health facilities in Kenya. Caregivers will benefit from screening for co-morbidity including HIV and Tuberculosis and advice on management will improve the quality of their lives. Impact will be ensured by: i) existing committee membership by the investigators, including within the Kenyan Ministry of Health and collaborative activities with UNICEF and other humanitarian agencies; ii) workshops and conferences in Kenya and internationally ; and iii) open-access publication.
Benefits to the wider public will include raised awareness on the prevalence and survival of infants with SAM and data to support rational for intervention trials to improve growth and survival.
Within the first 3 months after completion, preliminary findings will be disseminated and discussed with the Ministry of Health and UNICEF. Later, a full report will be shared with UNICEF and other national and international stakeholders. The report will aim to highlight on opportunities to improving the implementation of the current treatment guidelines. These will be shared at a national workshop, international conferences, at international advisory committees and published in open-access journals. Impact will be assessed by output being included in systematic reviews and being considered by committees that set guidelines and policies.
Project staff will all be trained in GCP/GCLP, ethics communication and consent, data entry, project management and anthropometry. Clinical staff within the hospital will be trained on best practises for diagnosis and management of severe acute malnutrition.