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.: PACTR201712002802638 Date of Approval: 27/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Collaborative Newborn Support Project
Official scientific title Improving Quality of Newborn Care in Bungoma County
Brief summary describing the background and objectives of the trial The Collaborative New-born Support Project will be implemented in Bungoma County from October 2015 to December 2018. It will tackle the challenge of neonatal deaths in Bungoma County that is among the highest in Kenya. Lack of critical infrastructure and skilled personnel and an incoherent community referral system for neonatal problems are key challenges facing the county health system. The goal of the project is reduced neonatal mortality ratio by 30% between October 2015 and April 2017 in Bungoma County. This will be achieved through setting up 7 special new-born care units in the sub county hospitals, strengthening 2 existing special care units, training and mentoring 36 health workers to be able to manage new-born health problems, providing best practice guidelines, developing a tele-health platform to enable the rural new-born carers consult paediatricians in making decisions and establishing a mobile phone based follow up system for neonates born within and without the health care system to enable mothers make timely health seeking decisions. Additionally, communities will be sensitized on availability and importance of seeking new-born care services in the new units. The project will mainstream neonatal care in a county with an unacceptably high neonatal mortality.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Newborn health,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2015
Actual trial start date 04/01/2016
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MKU/ERC/0096 Mount Kenya University Ethics Review Committee
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Telehealth platform 33 months evaluate the use of telehealth platform on improving quality of newborn care 250
Experimental Group call center service 21 months evaluate the use call center service on improving quality of newborn care 250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Newborns admitted in Newborn Units in Bungoma County during the study period. 2. Parent or guardian have access to mobile phone for follow up. 1. Newborns who may need refferal to facilities outside Bungoma County. 2. Babies for who consent by parent of guardian will not be granted. 3. Babies with severe congenital abnormalities 1 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 08/03/2016 Mount Kenya University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Gen Kago Road Thika P.O. Box 432-01000 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Facility based neonatal mortality Endline
Secondary Outcome Percentage of neonates with severe complications in the specialized neonatal units Anually
Secondary Outcome Percentage of health providers trained in neonatal care who adhere to expected neonatal standards of care mid term and endline
Secondary Outcome Number of follow -up calls to mothers with neonatal complications Monthly
Secondary Outcome Number of Tele- health consultations per month Monthly
Secondary Outcome Percentage of trained personnel assigned to specialised neonatal units Quarterly
Secondary Outcome % of mothers and babies who received post natal care within 48 hours of child birth in the selected health Facilities Quarterly
Secondary Outcome Proportion of neonates with severe complications referred to specialized neonatal centres Quarterly
Secondary Outcome Percentage of mothers or care givers able to identify at least three danger signs in new borns in the project area midterm and endline
Secondary Outcome Percentage of mothers or care givers able to identify at least three danger signs in new borns in the project area midterm and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Webuye Sub County Hospital Main Street Webuye Kenya
Chwele Sub County hospital Market street Chwele Kenya
Bumula SubCounty Hospital Mateka Road Bumula Kenya
Kapsokwony Sub County Hospital Main street Kapsokwony Kenya
Kimilili Sub County Hospital Bungoma Road Kimilili Kenya
Sinoko Sub County Hospital Main Street Sinoko Kenya
Tongaren Sub County Hospital Webuye road Tongaren Kenya
Sirisia Sub County Hospital Market street Sirisia Kenya
Bungoma County Refferal Hospital New Born Unit Hospital Street Bungoma Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
County Innovation Challenge Fund Waiyaki Way Nairobi P.O. Box 40612-0010 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mount Kenya University Gen Kago Road Thika 342-01000 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Kenya Pediatric Association Mara Road Nairobi 45821-00100 GPO Kenya
Fountain Africa Trust Lugonzo Estate Webuye Private Bag Kenya
Kenya Pediatric Association Mara Road Nairobi 45821-00100 GPO Kenya
Fountain Africa Trust Lugonzo Estate Webuye Private Bag Kenya
Kenya Pediatric Association Mara Road Nairobi 45821-00100 GPO Kenya
Fountain Africa Trust Lugonzo Estate Webuye Private Bag Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jesse Gitaka jgitaka@mku.ac.ke 254722425613 Thika Town
City Postal code Country Position/Affiliation
THIKA 01000 Kenya Lecturer
Role Name Email Phone Street address
Public Enquiries Daniel Gatungu dgatungu@mku.ac.ke +254725464767 Gen Kago Rd
City Postal code Country Position/Affiliation
THIKA 342-01000 Kenya Project officer
Role Name Email Phone Street address
Scientific Enquiries Jesse Gitaka jgitaka@mku.ac.ke 254722425613 Thika Town
City Postal code Country Position/Affiliation
THIKA 342-01000 Kenya Lecturer
REPORTING
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