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

Lead Research Organisation: KEMRI Wellcome Trust Research Programme
Department Name: Research

Abstract

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.

Technical Summary

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.

Planned Impact

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.

Publications

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Israel-Ballard K (2019) Call to action for equitable access to human milk for vulnerable infants. in The Lancet. Global health

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Mwangome M (2017) Diagnostic criteria for severe acute malnutrition among infants aged under 6 mo. in The American journal of clinical nutrition

 
Description Of 106 infants with acute malnutrition at admission, 51 met the inclusion criteria for the study. Most enrolled mothers had multiple breastfeeding challenges, which were predominantly technique based. Exclusive breastfeeding was 55% at admission and 81% at discharge; at discharge 67% of infants had attained a weight velocity of >5 g/kg/day for three consecutive days on breastmilk alone. Gains in weightforlength z score and weightforage z score were generally not sustained beyond 2 weeks afte
Exploitation Route Yes we provide details of the procedure followed and share in the supplimentary details of our standard operating procedures for others to follow and see if they achieve similar results
Sectors Education

URL https://onlinelibrary.wiley.com/doi/full/10.1111/mcn.12868
 
Description Africa Research Fellowship Award (AREF)
Amount £22,000 (GBP)
Funding ID MRF-157-0025-F-MWANG 
Organisation Medical Research Council (MRC) 
Department Medical Research Foundation
Sector Charity/Non Profit
Country United Kingdom
Start 02/2019 
End 07/2019
 
Description Health Systems Research Initiative (HSRI)
Amount £184,000 (GBP)
Funding ID MR/R002738/1 
Organisation Research Councils UK (RCUK) 
Sector Public
Country United Kingdom
Start 02/2018 
End 07/2019
 
Title Breastfeeding and infants under 6 months 
Description Funding for IBAMI study enabled drafting and piloting of case report forms for assessing breastfeeding and other aspects of health among sick infants under 6 months. These tools have now been adopted by the CHAIN network and are currently being applied in the 8 settings in 5 countries. 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2016 
Provided To Others? Yes  
Impact The tools we are currently using to assess breastfeeding in the under 6 months slightly differ from the currently recommended tools which would be limiting to this study population. This has forced practitioners to re-think the adoption of tools that may not have been piloted within their setting and study population. 
 
Title IBAMI REDCAP Database 
Description Data is stored in a MySQL database using the REDCap application . REDCap stores data and all system and project information in tables within a single MySQL database. Data can also be exported in several formats (CSV, JSON, or XML) for analysis. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact The REDCAP database is easy to manipulate by non-IT experts. This has ensured real time data entry as the Field worker is able to enter the data immediately it is collected. 
URL http://project-redcap.org/
 
Description MAMI 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution In the process of collaboration in analyzing historic birth cohort data from Bikunafaso
Collaborator Contribution Contribution is mainly technical co-authorship in manuscripts
Impact Publications
Start Year 2008
 
Description MoH (County Level) 
Organisation Kilifi County Hospital
Country Kenya 
Sector Hospitals 
PI Contribution Training on lactation management for malnourished infants organized by the study team was extended to other health workers within the hospital. Information on management of infants with severe acute malnutrition generated by the study is shared with the nutrition department to better management.
Collaborator Contribution The department of Nutrition within the Kilifi county Ministry of Health has seconded one of their pediatric nutritionists to work with the IBAMI team towards fulfilling the objectives of the study. Working with the peer supporters, the nutritionist works with the team to pilot the treatment protocol on re-lactation.
Impact Raised awareness on treatment of infants with malnutrition among the Kilifi county department of nutrition and among other health workers
Start Year 2016
 
Description MoH (National Level) 
Organisation Ministry of Health, Kenya
Country Kenya 
Sector Public 
PI Contribution Sharing of the research ideas with the Ministry of Health at the initiation and implementation stages of work. Involving the Programme Manager Maternal Infant and Young Child Nutrition at the national level and participating in programme workshops.
Collaborator Contribution The National Programme Manager Maternal Infant and Young Child Nutrition worked with the study team towards developing the lactation training materials and leading the group of experts in the lactation training for the study team and other health workers.
Impact Lactation training effected Lactation reference materials available for study team Ministry of Health's engagement with the study objectives will increase likelihood of findings being taken up.
Start Year 2016
 
Description UNICEF Kenya 
Organisation UNICEF
Country United States 
Sector Public 
PI Contribution The lead and co-investigators of this study initiated this collaboration and worked towards clarifying roles and responsibilities for the partnership. The lead investigator is responsible for sending in regular updates to the partner on study progress. The lead investigator recently partnered again with UNICEF in an application for funding from the Health System Research Initiative towards identifying the health systems factors that would affect integration of breastfeeding peer supporters within the health system in Kenya.
Collaborator Contribution UNICEF Kenya agreed to be IBAMI's technical expert. The study has partnered successfully with UNICEF to undertake lactation training among peer supporters and other health workers within the study hospital. UNICEF identified and facilitated the expert trainers and training materials for this training at a cost of 431,800Ksh. At the moment, UNICEF has continued to provide expertise by assigning their MIYCN country expert to advise the study on technical breastfeeding matters.
Impact Lactation training for the peer supporters and other health workers. Lactation reference materials for practical use in the study Available lactation expert advice throughout the study period Continuous engagement before and during the study will improve policy implementability
Start Year 2015
 
Description CHAIN International Annual Network Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact The lead investigator shared and discussed initial findings for IBAMI in the 2nd and 4th CHAIN annual meeting in Malawi. The audience was a mixture of researchers, practitioners, policy makers and supporters from the Non-Governmental organizations.
Year(s) Of Engagement Activity 2016,2017,2019
URL http://www.CHAIN-network.org
 
Description Engaging local health service providers 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Main purpose of meeting with the nurses and clinicians was to make them aware of the study's aims and objectives and request for their support in study activities. The study's engagement with this platform is continuous as the study is being undertaken in the hospital pediatric ward.
Year(s) Of Engagement Activity 2016,2018
 
Description GATES Foundation 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Presented preliminary findings from IBAMI study to make a case for future funding of interventions.
Year(s) Of Engagement Activity 2017,2019
 
Description International Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I presented preliminary findings of the IBAMI study at the International Unions of Nutrition Societies (IUNS) conference in Argentina
Year(s) Of Engagement Activity 2017
URL http://icn2017.com/
 
Description MAMI Technical Working Group Meeting 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact A meeting that brings together policy makers, Nutrition NGOs and Nutrition practitioners to discuss progress and future plans around the topic of management of malnutrition in Infants aged less than 6 months. I gave several presentations on different aspects of my work including sharing preliminary results from IBAMI study.
Year(s) Of Engagement Activity 2018,2019
 
Description MSF Conference_Sweden 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I was invited to give a presentation during the 2019 MSF pediatric day in Sweden. I presented on the general topic of malnutrition among infants aged below 6 months. During a follow-on discussion an interest in the related subject was expressed and a request to work together towards a concept note for research with MSF
Year(s) Of Engagement Activity 2019
 
Description USAID Nakuru 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact I was invited to give a presentation on the results of the IBAMI study. USAID Kenya and East Africa provides technical and financial support to Ministry of Health and County governments in Kenya to improve child survival. USAID has been supporting annual FP/RMNCAH Nutrition and WASH implementing partners meetings since 2014. This meeting brings together USAID, UN agencies, MOH and related sectors, Country Governments, implementing partners, Community, and Non-state actors to review progress.
Year(s) Of Engagement Activity 2019
 
Description WHO Wasting consultative meeting 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The WHO Department of Nutrition for Health and Development, in collaboration with the Department of Maternal, Newborn, Child and Adolescent Health will convene a technical consultation meeting in collaboration with UN partners in December 2019. The participants will include approximately 20-25 experts in the field of prevention and treatment of wasting and child health. The purpose of this meeting is to build consensus on the technical framing of wasting which will be the basis for the guideline scoping of wasting in infants and children, for supporting advocacy and messaging around wasting and under nutrition, as well as for discussing how to detect those at risk of mortality and
morbidity and what indicators are needed.
Year(s) Of Engagement Activity 2019
 
Description WaSt Technical Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I was invited to take part in a consultative meeting on Concurrent Wasting and Stunting (WaSt) a current project of the Emergency Nutrition Network. The main objectives of the meeting were;
To take stock of the WaSt TIG mortality analysis, reflecting on key outcomes of the analysis
To jointly consider and discuss the mortality analysis in light of other analyses
To discuss the implications of the analysis for programmes, policies and research
To agree on the next steps for this body of work (including additional data, further analysis, journal, timing and authorship)

A follow-on full TIG meeting is planned for June to hear of progress and discuss way froward for the project.
Year(s) Of Engagement Activity 2019