Malnutrition, InfantIBAMI-2NCT06372418
Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants
A study testing Breastfeeding peer support intervention in people with Malnutrition, Infant and Breastfeeding, Exclusive, run by University of Oxford.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 weeks
- Conditions the study is for
- Malnutrition, Infant, Breastfeeding, Exclusive
- What is being tested?
- Breastfeeding peer support intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enhancing Growth and Development Among Malnourished Infants Recovering From a Serious Illness (IBAMI-2)
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.
Read the 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.
- Conditions
- Malnutrition, Infant, Breastfeeding, Exclusive
- Being tested
- Breastfeeding peer support intervention, Standard Care
- Medical subject headings
- Infant Nutrition Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding peer support interventionOther
In addition to support as currently recommended by the World Health Organization (WHO) and National IMAM guidelines, care givers will receive a homebased individualized face to face support provided by breastfeeding peer supporters and phone call support upto 7 weeks post hospital discharge.
Standard CareOther
Caregivers will receive post-discharge support as currently recommended by the World Health Organization (WHO) and national IMAM guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding peer support intervention. | Experimental | In addition to support as currently recommended by the World Health Organization (WHO) and National IMAM guidelines, the intervention arm will receive a homebased individualized face to face support breastfeeding by peer supporters and phone support for 7 weeks post hospital discharge. Receives: Other: Breastfeeding peer support intervention |
| Standard of care | Active comparator | The Control arm will receive post-discharge support as currently recommended by the World Health Organization (WHO) and national IMAM guidelines, including providing linkage to available local breastfeeding support groups. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
The primary outcome for the trial is growth (weight gain) assessed at 26 weeks of age
Measured: At 26 weeks of age
Secondary outcomes (2)
Morbidity
Assess morbidity at 39 weeks and 52 weeks of age
Measured: At 39 weeks and 52 weeks of age
Mortality
To assess for mortality at the age of 39 to 52 weeks of age
Measured: At 39 to 52 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, InfantStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial: Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Mwangome, PhD, Principal investigator, KEMRI WELLCOME TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372418
- Sponsor's protocol ID
- KEMRI/SERU/CGMR-C/238/4326
- Acronym
- IBAMI-2
- Status last verified
- Apr 2024
- First submitted
- 10 Jul 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary information concerning the study will be posted on the https://clinicaltrials.gov/ platform and on Kenya Medical research Institution (KEMRI)/Wellcome Trust Research Programmes website. Data hosted on the Kemri-Wellcome Trust Research Program (KWTRP) Research Data Repository (https://dataverse.harvard.edu/dataverse/kwtrp will be issued with a Digital Object Identifier (DOI). This can be included as part of a data citation in publications, allowing the datasets underpinning a publication to be identified and accessed. Metadata and documentation about datasets held in KWTRP Data Repository will be publicly searchable and discoverable. Access to the archived data will be managed by the Data Governance committee which receives and reviews requests for both internal and external data sharing.
Publications
Kerac M, Blencowe H, Grijalva-Eternod C, McGrath M, Shoham J, Cole TJ, Seal A. Prevalence of wasting among under 6-month-old infants in developing countries and implications of new case definitions using WHO growth standards: a secondary data analysis. Arch Dis Child. 2011 Nov;96(11):1008-13. doi: 10.1136/adc.2010.191882. Epub 2011 Feb 2.
PubMed 21288999Grijalva-Eternod CS, Kerac M, McGrath M, Wilkinson C, Hirsch JC, Delchevalerie P, Seal AJ. Admission profile and discharge outcomes for infants aged less than 6 months admitted to inpatient therapeutic care in 10 countries. A secondary data analysis. Matern Child Nutr. 2017 Jul;13(3):e12345. doi: 10.1111/mcn.12345. Epub 2016 Jul 25.
PubMed 27453170Berkley JA, Ngari M, Thitiri J, Mwalekwa L, Timbwa M, Hamid F, Ali R, Shangala J, Mturi N, Jones KD, Alphan H, Mutai B, Bandika V, Hemed T, Awuondo K, Morpeth S, Kariuki S, Fegan G. Daily co-trimoxazole prophylaxis to prevent mortality in children with complicated severe acute malnutrition: a multicentre, double-blind, randomised placebo-controlled trial. Lancet Glob Health. 2016 Jul;4(7):e464-73. doi: 10.1016/S2214-109X(16)30096-1. Epub 2016 Jun 2.
PubMed 27265353Victora CG, de Onis M, Hallal PC, Blossner M, Shrimpton R. Worldwide timing of growth faltering: revisiting implications for interventions. Pediatrics. 2010 Mar;125(3):e473-80. doi: 10.1542/peds.2009-1519. Epub 2010 Feb 15.
PubMed 20156903Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, Tam Y, Sawadogo-Lewis T, Walker N. Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. Lancet Glob Health. 2020 Jul;8(7):e901-e908. doi: 10.1016/S2214-109X(20)30229-1. Epub 2020 May 12.
PubMed 32405459Vygen SB, Roberfroid D, Captier V, Kolsteren P. Treatment of severe acute malnutrition in infants aged <6 months in Niger. J Pediatr. 2013 Mar;162(3):515-521.e3. doi: 10.1016/j.jpeds.2012.09.008. Epub 2012 Oct 23.
PubMed 23092531Stewart RC. Maternal depression and infant growth: a review of recent evidence. Matern Child Nutr. 2007 Apr;3(2):94-107. doi: 10.1111/j.1740-8709.2007.00088.x.
PubMed 17355442Chisti MJ, Graham SM, Duke T, Ahmed T, Faruque AS, Ashraf H, Bardhan PK, Shahid AS, Shahunja KM, Salam MA. Post-discharge mortality in children with severe malnutrition and pneumonia in Bangladesh. PLoS One. 2014 Sep 16;9(9):e107663. doi: 10.1371/journal.pone.0107663. eCollection 2014.
PubMed 25225798Guideline: Updates on the Management of Severe Acute Malnutrition in Infants and Children. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK190328/
PubMed 24649519Health Mo. The Kenya National Intergrated Management of Acute Malnutrition (IMAM) guidelines. 2020
McGrath M. Updated review of 46 national guidelines on MAMI: Key findings. London: Emergency Nutrition Network; London School of Hygiene and Tropical Medicine; 2016.
Mwangome M, Murunga S, Kahindi J, Gwiyo P, Mwasho G, Talbert A, Kiige L, Samburu B, Mturi N, Abubakar A, Jones C, Berkley JA. Individualized breastfeeding support for acutely ill, malnourished infants under 6 months old. Matern Child Nutr. 2020 Jan;16(1):e12868. doi: 10.1111/mcn.12868. Epub 2019 Aug 2.
PubMed 31264337Kahindi J, Jones C, Berkley JA, Mwangome M. Establishing exclusive breastfeeding among in-patient malnourished infants in a rural Kenyan hospital: mothers' experiences of a peer supporter intervention. Int Breastfeed J. 2020 May 14;15(1):40. doi: 10.1186/s13006-020-00278-9.
PubMed 32408904Van Ryneveld M, Mwangome M, Kahindi J, Jones C. Mothers' experiences of exclusive breastfeeding in a postdischarge home setting. Matern Child Nutr. 2020 Oct;16(4):e13016. doi: 10.1111/mcn.13016. Epub 2020 Apr 21.
PubMed 32319227Chabeda S, Oluoch D, Mwangome M, Jones C. Infant malnutrition treatment in Kenya: Health worker and breastfeeding peer supporter experiences. Matern Child Nutr. 2021 Jul;17(3):e13148. doi: 10.1111/mcn.13148. Epub 2021 Feb 2.
PubMed 33528108