Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT06372418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007228', 'term': 'Infant Nutrition Disorders'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Fieldworkers collecting endpoint data at 6 months of age will be blinded to group allocation to avoid any bias subject to knowledge of group allocation.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control Trial:\n\nParticipants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': 'At 26 weeks of age', 'description': 'The primary outcome for the trial is growth (weight gain) assessed at 26 weeks of age'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'At 39 weeks and 52 weeks of age', 'description': 'Assess morbidity at 39 weeks and 52 weeks of age'}, {'measure': 'Mortality', 'timeFrame': 'At 39 to 52 weeks of age', 'description': 'To assess for mortality at the age of 39 to 52 weeks of age'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition, Infant', 'Breastfeeding, Exclusive']}, 'referencesModule': {'references': [{'pmid': '21288999', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27453170', 'type': 'BACKGROUND', 'citation': 'Grijalva-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.'}, {'pmid': '27265353', 'type': 'BACKGROUND', 'citation': 'Berkley 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.'}, {'pmid': '20156903', 'type': 'BACKGROUND', 'citation': 'Victora 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.'}, {'pmid': '32405459', 'type': 'BACKGROUND', 'citation': 'Roberton 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.'}, {'pmid': '23092531', 'type': 'BACKGROUND', 'citation': 'Vygen 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.'}, {'pmid': '17355442', 'type': 'BACKGROUND', 'citation': 'Stewart 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.'}, {'pmid': '25225798', 'type': 'BACKGROUND', 'citation': 'Chisti 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.'}, {'pmid': '24649519', 'type': 'BACKGROUND', 'citation': 'Guideline: 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/'}, {'type': 'BACKGROUND', 'citation': 'Health Mo. The Kenya National Intergrated Management of Acute Malnutrition (IMAM) guidelines. 2020'}, {'type': 'BACKGROUND', 'citation': 'McGrath M. Updated review of 46 national guidelines on MAMI: Key findings. London: Emergency Nutrition Network; London School of Hygiene and Tropical Medicine; 2016.'}, {'pmid': '31264337', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32408904', 'type': 'BACKGROUND', 'citation': "Kahindi 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."}, {'pmid': '32319227', 'type': 'BACKGROUND', 'citation': "Van 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."}, {'pmid': '33528108', 'type': 'BACKGROUND', 'citation': 'Chabeda 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.'}, {'type': 'BACKGROUND', 'citation': 'Kenya National Bureau of statistics. Kenya Demographic Health Survey 2014. Kenya National Bureau of Statistics; 2014.'}, {'pmid': '32138727', 'type': 'BACKGROUND', 'citation': 'Talbert A, Jones C, Mataza C, Berkley JA, Mwangome M. Exclusive breastfeeding in first-time mothers in rural Kenya: a longitudinal observational study of feeding patterns in the first six months of life. Int Breastfeed J. 2020 Mar 5;15(1):17. doi: 10.1186/s13006-020-00260-5.'}, {'pmid': '17302642', 'type': 'BACKGROUND', 'citation': 'Eickmann SH, de Lira PI, Lima Mde C, Coutinho SB, Teixeira Mde L, Ashworth A. Breast feeding and mental and motor development at 12 months in a low-income population in northeast Brazil. Paediatr Perinat Epidemiol. 2007 Mar;21(2):129-37. doi: 10.1111/j.1365-3016.2007.00795.x.'}, {'pmid': '15841896', 'type': 'BACKGROUND', 'citation': "O'Sullivan AK, Thompson D, Drummond MF. Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations? Value Health. 2005 Jan-Feb;8(1):67-79. doi: 10.1111/j.1524-4733.2005.03065.x."}, {'type': 'BACKGROUND', 'citation': 'Petrou S. Rationale and methodology for trial-based economic evaluation. . Clinical Investigation. 2012;2(12).'}, {'type': 'BACKGROUND', 'citation': 'Lloyd-Williams H, Edwards RT. Sample size calculation in trials of public health interventions: a discussion of implications for health economists. The Lancet. 2013;382.'}, {'pmid': '20920241', 'type': 'BACKGROUND', 'citation': 'Harding R, Simms V, Penfold S, McCrone P, Moreland S, Downing J, Powell RA, Mwangi-Powell F, Namisango E, Fayers P, Curtis S, Higginson IJ. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol. BMC Public Health. 2010 Sep 29;10:584. doi: 10.1186/1471-2458-10-584.'}, {'pmid': '22152173', 'type': 'BACKGROUND', 'citation': 'Simpson KN, Baran RW, Kirbach SE, Dietz B. Economics of switching to second-line antiretroviral therapy with lopinavir/ritonavir in Africa: estimates based on DART trial results and costs for Uganda and Kenya. Value Health. 2011 Dec;14(8):1048-54. doi: 10.1016/j.jval.2011.06.011. Epub 2011 Nov 6.'}, {'pmid': '29698176', 'type': 'BACKGROUND', 'citation': 'Constenla D, Armien B, Arredondo J, Carabali M, Carrasquilla G, Castro R, Durand L, Duran-Arenas L, Garcia ME, Gallegos RV, Gontes ML, Lopez JG, McFarlane C, Montoya R, Sartori AM, Siqueira JB, Martelli CT. Costing Dengue Fever Cases and Outbreaks: Recommendations from a Costing Dengue Working Group in the Americas. Value Health Reg Issues. 2015 Dec;8:80-91. doi: 10.1016/j.vhri.2015.06.001. Epub 2015 Jul 28.'}, {'type': 'BACKGROUND', 'citation': 'Kirkwood B. R, Sterne JAC. Essential Medical Statistics. Second Edition ed. Oxford: Blackwells publishing Ltd; 2003.'}, {'type': 'BACKGROUND', 'citation': 'Ministry of Health. Guidelines for Prevention of Mother To Child Transmission (PMTCT) of HIV/AIDS in Kenya 2012 [Fourth:[Available from: http://www.faces-kenya.org/wp-content/uploads/2012/11/Guidelines-for-PMTCT-of-HIVAIDS-in-Kenya-1_2012.pdf.'}, {'type': 'BACKGROUND', 'citation': 'WHO, UNICEF. Infant and Young Child Feeding Counselling: An intergrated Course. Geneva: Worls Health Organization; 2006.'}, {'type': 'BACKGROUND', 'citation': 'Corbett M. Severe Malnutrition in the infants less than 6 months: Use of Supplemental Suckling Technique 2000 [Available from: http://fex.ennonline.net/9/tfp.'}, {'type': 'BACKGROUND', 'citation': 'Ministry of Health. National Guidelines for Intergrated Management of Acute Malnutrition 2009 [Available from: http://www.cmamforum.org/Pool/Resources/Kenya-MoH-IMAM-Guideline-June-2009.pdf.'}, {'pmid': '18727851', 'type': 'BACKGROUND', 'citation': 'Abubakar A, Holding P, van Baar A, Newton CR, van de Vijver FJ. Monitoring psychomotor development in a resource-limited setting: an evaluation of the Kilifi Developmental Inventory. Ann Trop Paediatr. 2008 Sep;28(3):217-26. doi: 10.1179/146532808X335679.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nProviding 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInfants admitted to Kilifi County Hospital (KCH) aged between 4 weeks and 12 weeks old\n\nAND Wasting or underweight assessed by Weight-for-length Z-score (WFLz)\\<-2 OR Weight-for-age Z-score (WFAz) \\<-2\n\nOR Mid upper arm circumference (MUAC)\\<110mm OR presence of bilateral pitting oedema AND\n\n* Any possibility to breastfeed (carer of reproductive age willing to breastfeed and infant without clinical abnormalities obstructing breastfeeding\n* Caregivers consent to participation in the study\n\nExclusion Criteria:\n\nInfants 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.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06372418', 'acronym': 'IBAMI-2', 'briefTitle': 'Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Enhancing Growth and Development Among Malnourished Infants Recovering From a Serious Illness (IBAMI-2)', 'orgStudyIdInfo': {'id': 'KEMRI/SERU/CGMR-C/238/4326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breastfeeding peer support intervention.', 'description': '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.', 'interventionNames': ['Other: Breastfeeding peer support intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': '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.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Breastfeeding peer support intervention', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Breastfeeding peer support intervention.']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Caregivers will receive post-discharge support as currently recommended by the World Health Organization (WHO) and national IMAM guidelines.', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fridah Munene', 'role': 'CONTACT', 'email': 'fmunene@kemri-wellcome.org', 'phone': '+254 417 522 063'}, {'name': 'Grace Dena', 'role': 'CONTACT', 'email': 'gdena@kemri-wellcome.org', 'phone': '+254 417 522 063'}], 'overallOfficials': [{'name': 'Martha Mwangome, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KEMRI WELLCOME TRUST'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '3 years', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Apply to the Data Governance Committee: dgc@kemri-wellcome.org'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}