Plain English Summary
Background and study aims
Normal body temperature is around 37C. Hypothermia occurs when body temperature drops below 35C. Babies are more prone to developing hypothermia because their bodies' ability to regulate temperature isn't fully developed. The aim of this study is to assess the effectiveness of the Embrace infant warmer at reducing hypothermia in newborns.
Who can participate?
Mothers and newborns in Karnataka, India
What does the study involve?
Areas where the warmer has been distributed are compared to areas where they are not used. Two types of data are collected: household survey data and newborn temperature measurements from hospitals. The costs associated with delivery , the readmission and referral rates of infants within 14 days after birth, and behavioural changes of health providers and mothers in response to the warmer are all measured.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Stanford University (USA)
When is the study starting and how long is it expected to run for?
March 2012 to January 2013
Who is funding the study?
1. Peery Foundation (USA)
2. Freeman Spogli Institute, Stanford University (USA)
3. Duke University (USA)
Who is the main contact?
Prof. Grant Miller
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An effectiveness evaluation of the Embrace Infant Warmer: observational study of demand and effectiveness
Acronym
Study hypothesis
Evaluate the health impact and behavioral response to the presence of the Embrace infant warmer in rural Karnataka, India.
Ethics approval
Not provided at time of registration
Study design
Observational non-randomised trial
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Maternal and child health
Intervention
The association between price and adoption decisions will be evaluated as well as any subsequent associations with health outcomes and medical expenditures of the Embrace Infant Warmer in rural Karnataka, India.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Diffusion of the Embrace warmer through professional/social networks
2. Responsiveness of patient demand to improvements in clinical quality
3. Responsiveness of provider effort to improvements in medical technology
4. Changes in newborn warmth practices in response to the warmer
5. Price responsiveness among maternity care providers
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2012
Overall trial end date
04/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Mothers who have given birth to children in Karnataka, India
2. Health providers in rural Karnataka
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2550 neonates
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/03/2012
Recruitment end date
04/01/2013
Locations
Countries of recruitment
India
Trial participating centre
Stanford University
Stanford
CA 94305 2004
United States of America
Sponsor information
Organisation
Stanford University (USA)
Sponsor details
450 Serra Mall
Stanford
CA 94305 2004
United States of America
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Peery Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Freeman Spogli Institute for International Studies At Stanford University
Alternative name(s)
Freeman Spogli Institute for International Studies At Stanford University
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United States of America
Funder name
Duke University
Alternative name(s)
Duke
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list