|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201607001698226 |
|
Date of registration:
|
28/06/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Averting deaths among preterm and low-birth weight neonates using Community Kangaroo Mother Care intervention: A cluster randomized trial
|
|
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) |
|
Date of first enrolment:
|
01/07/2016 |
|
Target sample size:
|
266 |
|
Recruitment status: |
Other |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1698 |
|
Study type:
|
Interventional |
|
Study design:
|
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.
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Kenya
| | | | | | | |
|
Contacts
|
|
Name:
|
Peter
Muriuki |
|
Address:
|
Manga close
00100
Nairobi
Kenya |
|
Telephone:
|
+254204001000 |
|
Email:
|
pmuriuki@aphrc.org |
|
Affiliation:
|
Research Assistant |
|
|
Name:
|
Abdhalah
Ziraba |
|
Address:
|
Manga Close
00100
Nairobi
Kenya |
|
Telephone:
|
+254204001000 |
|
Email:
|
aziraba@aphrc.org |
|
Affiliation:
|
Associate Research Scientist |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 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
Exclusion criteria: 1) Sick neonate (with danger signs)
2) Neonate not recruited within 7 days after birth
Age minimum:
0 Day(s)
Age maximum:
28 Day(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
prematurity, low birth weight, neonatal mortality
|
Neonatal Diseases
prematurity, low birth weight, neonatal mortality
|
|
Neonatal Diseases
|
|
Intervention(s)
|
|
Standard counselling on maternal and newborn care by trained Community Health Volunteers
|
|
Community Health Volunteer-supported kangaroo mother care
|
|
|
|
Primary Outcome(s)
|
|
Neonatal death
|
|
Secondary Outcome(s)
|
|
Weight gain
|
|
Breastfeeding
|
|
Source(s) of Monetary Support
|
|
Children's Prize Foundation
|
|
Ethics review
|
Status: Approved
Approval date: 18/12/2015
Contact:
AMREF Ethics and Scientific Review Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|