|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 August 2016 |
|
Main ID: |
NCT02208960 |
|
Date of registration:
|
01/08/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Newborn Kit to Save Lives and Brains in Kenya
|
|
Scientific title:
|
An Integrated Toolkit to Save Newborn Lives and Brains in Kenya |
|
Date of first enrolment:
|
November 2014 |
|
Target sample size:
|
2294 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02208960 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Kenya
| | | | | | | |
|
Contacts
|
|
Name:
|
Shaun K Morris, MD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Hospital for Sick Children |
|
|
Name:
|
Robert Armstrong |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aga Khan University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
i. All pregnant women in parts of study clusters covered by CHW program and their home- or
facility-born live newborns.
ii. Mothers intending to maintain residence in study area for first 12 months of newborn's
life.
Exclusion Criteria:
i. Failure to provide consent to enroll in study (intervention or control clusters).
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Neurodevelopment
|
|
Neonatal Mortality
|
|
Intervention(s)
|
|
Behavioral: Neonatal Stimulation
|
|
Device: Neonatal Kit
|
|
Primary Outcome(s)
|
|
Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment
[Time Frame: 12 months of age]
|
|
Secondary Outcome(s)
|
|
Health facility use
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Incidence of omphalitis
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Cases of hyperthermia identified
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Neonatal mortality
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Incidence of severe infection
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Cases of hypothermia identified
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Number of LBW babies identified
[Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life]
|
|
Secondary ID(s)
|
|
1000044053
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|