An effectiveness evaluation of the Embrace Infant Warmer
| ISRCTN | ISRCTN19875148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19875148 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/12/2011
- Registration date
- 16/02/2012
- Last edited
- 26/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Stanford University
117 Encina Commons
Stanford
CA 94305 2004
United States of America
Study information
| Study design | Observational non-randomised trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An effectiveness evaluation of the Embrace Infant Warmer: observational study of demand and effectiveness |
| Study objectives | Evaluate the health impact and behavioral response to the presence of the Embrace infant warmer in rural Karnataka, India. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2012 |
| Completion date | 04/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2550 neonates |
| Key inclusion criteria | 1. Mothers who have given birth to children in Karnataka, India 2. Health providers in rural Karnataka |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 04/01/2013 |
Locations
Countries of recruitment
- India
- United States of America
Study participating centre
CA 94305 2004
United States of America
Sponsor information
University/education
450 Serra Mall
Stanford
CA 94305 2004
United States of America
| Website | http://www.stanford.edu/ |
|---|---|
"ROR" |
https://ror.org/00f54p054 |
Funders
Funder type
Research organisation
No information available
Private sector organisation / Research institutes and centers
- Alternative name(s)
- Freeman Spogli Institute for International Studies At Stanford University, THE FREEMAN SPOGLI INSTITUTE FOR INTERNATIONAL STUDIES, The Freeman Spogli Institute for International Studies at Stanford, Freeman Spogli Institute for International Studies, Stanford University's Freeman Spogli Institute for International Studies, Stanford's Freeman Spogli Institute for International Studies, Stanford University, Freeman Spogli Institute for International Studies, Stanford University Freeman Spogli Institute for International Studies, FSI Stanford, FSIStanford, FSIIS, FSI
- Location
- United States of America
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Duke, Universitas Dukiana, Brown School, Union Institute, Normal College, Trinity College, DU
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
26/05/2017: Plain English summary added.
