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.: PACTR201812681228156 Date of Approval: 20/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mother-Baby Friendly Initiative Plus: An Integrated Model for Strengthening Access to Human Milk in Kenya
Official scientific title Pilot Testing of the Mother and Baby Friendly Initiative plus Model for Human Milk Banking at Pumwani Maternity Hospital in Nairobi County (MBFI+ Project)
Brief summary describing the background and objectives of the trial Kenya has a high burden of neonatal deaths (22/1,000 live births) and loses an estimated 39,000 infants every year. Evidence shows that optimal breastfeeding (BF) is among the most powerful interventions for reducing infant mortality. Many babies, however, lack access to their mother’s milk because of suboptimal BF practices or because the mother is sick, unavailable, or dead. When BF is not an option, the World Health Organization (WHO) recommends Donated Human Milk (DHM) as a lifesaving alternative, particularly for vulnerable infants, and has called for global scale-up of Human Milk Banks (HMBs) to increase access. Nevertheless, none of the sub-Saharan African countries including Kenya is yet to implement the global best practice of providing safe DHM from HMBs for children who cannot access their mother’s own milk. The Kenya Ministry of Health seeks to establish the first human milk bank in the region and is requesting technical assistance from PATH for systems strengthening and evaluation. The formative assessment conducted in 2016 and 2017 on the potential acceptability of the use of donor human milk and the feasibility of establishing HMBs demonstrated potential feasibility, acceptability and need for donor human milk. However, there is still a paucity of evidence on the operational feasibility and implementation challenges of the Mother-Baby Friendly Initiative plus (MBFI+) model that combines an actual HMB, Kangaroo Mother Care and a breastfeeding promotion center. This implementation research, therefore, aims at assessing the MoH-led operational feasibility of establishing an MBFI+ program that includes an HMB, Kangaroo Mother Care and breastfeeding promotion in Kenya. The study will further evaluate the potential effectiveness of an integrated MBFI+ model in improving neonatal health and nutrition outcomes, the cost of implementing the MBFI+ and the challenges and facilitators of implementation.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Breastfeeding
Anticipated trial start date 05/10/2018
Actual trial start date 05/10/2018
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 113
Actual target sample size (number of participants) 113
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mother and Baby Friendly Initiative plus Model for Human Milk Banking NA 6 months The study plans to evaluate the improvement of the upcoming human milk bank facility through uptake of the ministry of health-led MBFI+ model and thereby increasing the use of human milk for the feeding of admitted neonates. Following the MBFI+ approach as outlined in the Kenya National HMB guidelines, increased exposure to human milk will be achieved by establishing the following components for a comprehensive and integrated newborn nutrition program: 1. Gold-standard human milk bank procedures to ensure safe collection, process, and provision of safe donated human milk. According to the newly developed national guidelines, the human milk is donated voluntarily by healthy lactating mothers who have extra breast milk without compromising the nutritional needs of their own baby, and/or mothers whose babies are admitted in newborn intensive care unit and cannot be fed due to illness. Donors are not paid for milk donation. Lactating women who are HIV, VDRL or hepatitis B positive, have a history of drug abuse or alcohol intake, have acute systemic or breast infection or are taking drugs known to have adverse effects on neonates are excluded. 2. Lactation support to provide mothers with breastfeeding support, lactation counselling, and support for kangaroo mother care. 3. Concomitant care throughout the study enrolled where neonates will continue to receive standard treatment practised in the study hospital. 4. Milk handling and storage which is the responsibility of the implementation team (Ministry of Health, Pumwani Hospital). The process of ensuring the safety and quality of milk will commence by assembling a multidisciplinary team (lead by a neonatologist) and instituting a standard Hazard Analysis Critical Control Points (HACCP). In addition; Standard Operating Procedures (SOP) will be developed at all (six) core processes and eleven support processes to ensure consistent and standard implementation. 113
Control Group Standard care in the hospital NA 6 Months Implementation of the baby friendly hospital initiative, without the human milk bank. Unenrolled infants will receive the standard of care given at the hospital; neither enrollment nor withdrawal status will affect the standard of care received by the neonates. 113 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Vulnerable neonates (very low and low birth weight, premature, and very sick neonates) born and admitted in the newborn unit in Pumwani maternity hospital. Mothers of vulnerable neonates above 15 years of age Mothers of vulnerable neonates (very low and low birth weight, premature and very sick neonates) born and admitted in the newborn unit in Pumwani maternity hospital. Mothers of healthy neonates born in Pumwani maternity hospital admitted in the post-delivery or postnatal wards. Mothers of eligible neonates who give to consent to participate in the study. Health workers (Nurses, pediatricians, lactation managers and nutritionists) working in Pumwani maternity hospital's newborn unit and the postnatal/ post delivery wards. Human milk bank staff. Pumwani hospital management team ( Director of medical/health services and managers of the pediatric, maternity ward, mother and child clinic) Policy and decision makers including the Kenya Ministry of Health officials. Mothers who donated their breastmilk to the human milk bank and those whose children received donated human milk from the human milk bank Vulnerable neonates (very low and low birth weight, premature and very sick neonates) not born in but admitted in Pumwani maternity hospital's newborn unit. Mothers of vulnerable neonates below 15 years of age. Mothers of vulnerable neonates (very low and low birth weight, premature and very sick neonates) not born in but admitted in Pumwani maternity hospital newborn unit. Mothers of eligible neonates not born in Pumwani maternity hospital but admitted in the post-delivery or postnatal wards Mothers of eligible neonates who declined to consent to participate in the study Eligible health workers who do not consent to participate in the study Human milk bank staff who do not consent to participate in the study Eligible Pumwani hospital management team who do not consent to participate in the study Eligible Policy and decision makers who decline to give consent to participate in the study Mothers who donate their breast milk to the human milk bank and those whose children receive donated human milk from the human milk bank but decline to give consent to participate in the study New born: 0 Day-1 Month 0 Day(s) 28 Day(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 13/09/2018 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
54840 Off Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Exclusive breastfeeding by either mother own milk and/ or donated human milk during the hospital stay Baseline, implementation period and endline
Secondary Outcome Use of human milk, mother's own milk or donated human milk, for first feed Baseline, implementation and endline
Secondary Outcome Use of donated human milk Implementation and end line
Secondary Outcome Time at the initiation of breastfeeding or the provision of human milk Baseline, intervention and endline
Secondary Outcome Timely initiation of breastfeeding Baseline, implementation and endline
Secondary Outcome Knowledge, Attitude and Practice of mothers or caregivers on breastfeeding, donating breast milk, use of donor human milk and kangaroo mother care Baseline, implementation and endline
Secondary Outcome Experiences of the mothers donating breastmilk and use donated human milk by their children Baseline, implementation and endline
Secondary Outcome Experiences (Benefits, risks, barriers and facilitators) of the health workers, hospital managers and the implementers in implementing the human milk bank Implementation and endline
Secondary Outcome Views and experiences of caregivers on the mother-baby friendly initiative, MBFI+, model Baseline, implementation and end line
Secondary Outcome Experiences (Benefits, risks, barriers and facilitators) by the health workers, hospital managers and the implementers in implementing the MBFI+ model implementation and endline
Secondary Outcome Cost of establishing the MBFI+ model Implementation and endline
Secondary Outcome Hospital case fatality rate Baseline, implementation and endline
Secondary Outcome Discharge* rate for LBW/VLBW. Deaths during the hospital stay, referral and leaving the hospital against medical advice will be not be included in the discharge Baseline, implementation and endline
Secondary Outcome The incidence of Necrotizing Enterocolitis (NEC) (less than equal to stage1). Deaths during the hospital stay, referral and leaving the hospital against medical advice will be not be included in the discharge Baseline, implementation and endline
Secondary Outcome Discharge without developing late-onset sepsis or NEC (less or equal to stage1) during the hospital stay. Deaths during the hospital stay, referral and leaving the hospital against medical advice will be not be included in the discharge Baseline, implementation and endline
Secondary Outcome Proven late-onset sepsis during a hospital stay Baseline, implementation and end line
Secondary Outcome Duration of hospital stay Baseline, implementation and end line
Secondary Outcome Duration of newborn unit stay Baseline, implementation and baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pumwani Maternity Hospital 42849 Muinami Street, Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
PATH Kenya ACS Plaza, 4th floor Lenana Road, PO Box 76634 Nairobi 00508 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Population and Health Research Center Manga Close, Off Kirawa Road, P.O Box 10787 Nairobi 00100 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
PATH Kenya Lenana Road P.O Box 76634 Nairobi 00508 Kenya
Ministry of health Kenya Unit of Nutrition and Dietetic Kenyatta Hospital, P.O Box 30016 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Kimani Murage ekimani@aphrc.org +2540204001000 Manga Close, Off Kirawa Road, P.O Box 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Scientist African population and health research center
Role Name Email Phone Street address
Public Enquiries Sheena Kayira skayira@aphrc.org +254204001000 Manga Close, Off Kirawa Road, P.O BOX 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Senior Development Officer African Population and Health Research Center
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Kimani ekimani@aphrc.org +254204001000 Manga Close, Off Kirawa Road, P.O Box 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Scientist African Population and Health Research Center
Role Name Email Phone Street address
Scientific Enquiries Taddese Zerfu tzerfu@aphrc.org +2540204001000 Manga Close, Off Kirawa Road, P.O Box 10787
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Post Doctoral Fellow African Population and Health Research Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Qualitative and Quantitative deindentified data sets. All datasets shared through the APHRC Microdata Portal are fully anonymized with all individual identifiers removed and noise added on sensitive variables (i.e. longitudinal datasets) Analytic Code,Clinical Study Report,Informed Consent Form,Study Protocol APHRC data (particularly cross-sectional data) for external users may be released to the public domain two years after the release of analytical data. The 24-month embargo is meant to enable investigators and other staff members on the project to finalize defined papers addressing core study objects and other interested APHRC staff to use the data. Data requests will be processed within five working days. Once the data request is processed, a notification email will be sent to the applicant. In case of approval, the email will provide instructions for free download of the requested dataset. Data can be accessed by collaborative partners, graduate students and other external such as government departments, UN agencies, or other strategic partners. The centre will generate tables and indicators requested and, if necessary, data abstraction costs may be incurred. External users (non-APHRC staff) and collaborative partners will fill an online request form and commit to abide by the guidelines for data use specified on the form. Authorization will be granted by the Director of Research, in consultation with the concerned Principal Investigator and Program Leader. The data will be made on a case by case basis, the following APHRC data sharing guidelines will apply in considering such applications.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://aphrc.org/welcome-to-the-aphrc-microdata-portal 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