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.: PACTR201607001698226 Date of Approval: 28/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Averting deaths among preterm and low-birth weight neonates using Community Kangaroo Mother Care intervention: A cluster randomized trial
Official scientific title Averting deaths among preterm and low-birth weight neonates using Community Kangaroo Mother Care intervention: A cluster randomized trial in two Nairobi informal settlements (slums)
Brief summary describing the background and objectives of the trial Background: Recent data show that child survival indicators in developing countries are improving. However, progress in improving neonatal survival has been slow. Globally, about 15 million babies are born premature and out of these, each year, 1 million die of complications of prematurity. In Kenya, many deliveries still take place at home and assess to interventions for prematurity and low birth weight remain low. The standard management of prematurity and low birth weight babies is expensive and entails keeping the neonate in a healthcare facility for weeks and because of this compliance is low. In this study, we assess the value of using kangaroo mother care at home for preterm (<37 weeks gestational age) or low birth weight (<2500g) neonates. The study uses a cluster randomized controlled trial design in two informal settlements in Nairobi. Each of the two settlements has 7 villages of comparable size. Villages will be randomized either into intervention or control arms. The intervention will be a Community Health Volunteer-supported Kangaroo Mother Care package (skin-to-skin contact, breast feeding, identification of danger signs, and referral). The control clusters will receive information on newborn care including for low birth weight and preterm babies as per the Kenya Community Maternal and Newborn Care guidelines. The outcomes will include weight gain, exclusive breast feeding, referral and death. Each neonate will be followed up to 28 days with 9 follow-up and data collection points. Objectives: 1) To assess the feasibility and uptake of kangaroo mother care at the community level 2) To determine the effectiveness of community-based kangaroo mother care in reducing the risk of preterm and low birth weight deaths. 3) To assess the cost-effectiveness of delivering kangaroo mother care at community level in averting deaths among preterm and low birth weight neonates.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CKMC
Disease(s) or condition(s) being studied Neonatal Diseases,prematurity, low birth weight, neonatal mortality
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2016
Actual trial start date
Anticipated date of last follow up 28/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 266
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 Simple randomisation using a radomisation table created by a computer software program Randomization is a based on clusters (villages). Clusters were assigned non-identifying unique IDs and these were passed on to statistician not involved in the project to randomly assign them to either control or intervention group. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community Health Volunteer-supported kangaroo mother care Trained before birth, follow up soon after birth, 12hrs, 24hrs, 36hrs, 48hrs, 7 days, 14 days, 21 days and 28 days 28 days Kangaroo mother care provided at home by mother who is trained by community health volunteers: Keys components include skin-to-skin contact, breastfeeding, identification of danger signs and referral 133
Control Group Standard counselling on maternal and newborn care by trained Community Health Volunteers Counselling before birth, follow up soon after birth, 12hrs, 24hrs, 36hrs, 48hrs, 7 days, 14 days, 21 days and 28 days 28 days Standard counselling and provision of information on maternal and newborn care by trained Community Health Volunteers 133
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Prematurity (born before 37 weeks of gestation) 2) Low birth weight (less than 2500 grams) 3) Born to a mother who is usual resident in the surveillance area 1) Sick neonate (with danger signs) 2) Neonate not recruited within 7 days after birth 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 18/12/2015 AMREF Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Langata Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neonatal death Birth; 12 hours; 24 hours; 36 hours; 48 hours; 7 days; 14 days; 21 days and 28 days
Secondary Outcome Weight gain Birth; 7 days; 14 days; 21 days and 28 days
Secondary Outcome Breastfeeding Birth; 12hrs; 24 hrs 36 hrs; 48 hrs; 7 days; 14 days; 21 days and; 28 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
African Population and Health Research Center Manga Close, Kitisuru Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Children's Prize Foundation 12030 Sunrise Valley Drive, Ste. 450 Reston, Virginia 20191 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Population and Health Research Center Manga close, Kitisuru Nairobi 00100 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Division of Child and Adolescent Health Ministry of Public Health and Sanitation KNH Complex, Upper Hill Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdhalah Ziraba aziraba@aphrc.org +254204001000 Manga Close, Kitisuru
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Associate Research scientist
Role Name Email Phone Street address
Public Enquiries Peter Muriuki pmuriuki@aphrc.org +254204001000 Manga close
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Abdhalah Ziraba aziraba@aphrc.org +254204001000 Manga Close
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Associate Research Scientist
REPORTING
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Result URL Hyperlinks
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