Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306789094184 Date of Approval: 28/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Providing breastfeeding support after discharge from hospital in order to improve growth and development of malnourished infants recovering from a serious illness
Official scientific title Enhancing growth and development among malnourished infants recovering from a serious illness (IBAMI2)
Brief summary describing the background and objectives of the trial 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 hospitalised malnourished infants u6m.The study achieved 81% infants exclusive breastfeeding by discharge with 67% attaining the WHO recommended growth velocity on breastmilk alone. However, when infants were followed up 6 weeks after discharge, the criteria for full nutritional recovery (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.Phase 1 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
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IBAMI 2
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Breastfeeding support
Anticipated trial start date 30/10/2023
Actual trial start date
Anticipated date of last follow up 30/10/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Breastfeeding support intervention Breastfeeding peer supporters will be trained and facilitated to implement the intervention in a series of scheduled home visits. Every mother-infant dyad will receive 3 scheduled home visits: initial visit in the first week and subsequently visits every 3 weeks from the first visit i.e. 1st, 4th and 7th week after discharge and 3phone calls with the initial call within 48hrs post discharge and subsequent call week 2 and week 5. Seven weeks post discharge from hospital In addition to standard care, every mother-infant dyad in the intervention arm will; between discharge and 21 weeks of age , receive 3 scheduled home visit by a trained breastfeeding peer supporter, 3 phone call support, counselling to a breastfeeding buddy ( of mothers' choice) for social support and linkage to the health system for psychosocial support if needed by mother and other if available. The 3 home visits will be implemented within 7 weeks post hospital discharge scheduled with the initial visit in the first week and subsequently visit every 3 weeks from the first visit i.e 1st, 4th and 7th weeks, then, the first phone call will be implemented within 48hours post discharge and subsequent will be implemented after every home visit i.e. week 2 and week 5. 125
Control Group Standard care arm Caregivers will receive post-discharge support as currently recommended by the WHO and national IMAM guidelines, including providing linkage to available local breastfeeding support groups. Seven weeks post hospital discharge. Standard care arm: Caregivers will receive post-discharge support as currently recommended by the WHO and national IMAM guidelines, including providing linkage to available local breastfeeding support groups (9). However, such groups tend to be scattered, often supported by international NGOs and not linked to the public hospital system. Hence, at discharge, mothers will be advised to monitor infant’s weight and present infants with suspected weight loss to the nearest health facility for nutritional support. 125 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Infants admitted to KCH aged between 4 weeks and 12 weeks old AND Wasting or underweight assessed by WFLz<-2 OR WFAz<-2 OR MUAC<110mm OR presence of bilateral pitting oedema(9) 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 • 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. OR • Infants whose caregivers refuse to consent Infant: 13 Month(s)-24 Month(s) 4 Week(s) 12 Week(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/11/2022 SERU
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome for the trial is growth (weight gain) assessed at age 6 months At six month of age of each participant
Secondary Outcome Secondary outcome will be assessed at 9 and 12 months of age to assess mortality, morbidity and neurodevelopmental outcomes. At 9 and 12 months of age for each participant.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilifi County Hospital Bofa Road kilifi Kilifi 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Gibbs building Euston Road London NWI 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oxford University Wellington squire Oxford Oxford OX12JD United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Martha Mwangome mmwangome@kemr-wellcome.org +254733289040 Bofa Road
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Frida Munene fmunene@kemri-wellcome.org +254717638970 Bofa Road
City Postal code Country Position/Affiliation
kilifi 80108 Kenya Research Officer
Role Name Email Phone Street address
Public Enquiries Salim Mwalukore smwalukore@kemri-wellcome.org +254723342780 Bofa Road
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Community Liaison manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant data will be subject to the data protection and security policies of the KEMRI/Wellcome Trust Research Programme (KWTRP). Data will be stored in a GCP compliant database using the application like OpenClinica electronic Data Capture system https://www.openclinica.com/ . OpenClinica stores its data and all system and project information in tables within a Postgres SQL database. Informed Consent Form,Study Protocol Data will be exported in several formats (CSV, JSON, or XML). For analysis the data will be exported directly to stata (version 13.2) statistical software. The database will be hosted at the KWTRP in Kilifi and remote entry performed by a secure web-based interface or using secure Virtual Private Network (VPN). Data will be stored in password secured computer folders and only accessible to the study team. The computer will be connected to the server which is backed up frequently. The qualitative data will be anonymised on transcription and the anonymised transcripts will be stored on the KWTRP database
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.openclinica.com/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information