An effectiveness evaluation of the Embrace Infant Warmer
| ISRCTN | ISRCTN19875148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19875148 |
| Protocol serial number | N/A |
| Sponsor | Stanford University (USA) |
| Funders | Peery Foundation (USA), Freeman Spogli Institute for International Studies At Stanford University, Duke University |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Observational non-randomised trial |
| Secondary study design | Case-control study |
| Study type | Participant 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(s) |
1. Diffusion of the Embrace warmer through professional/social networks |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 04/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2550 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/05/2017: Plain English summary added.
