Condition category
Not Applicable
Date applied
16/12/2011
Date assigned
16/02/2012
Last edited
26/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Grant Miller

ORCID ID

Contact details

Stanford University
117 Encina Commons
Stanford
CA 94305 2004
United States of America

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 measures

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

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

http://www.stanford.edu/

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, FSI

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

Funder name

Duke University

Alternative name(s)

Duke

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/05/2017: Plain English summary added.