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

Plain English Summary

Lay summary under review 3

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 below to request a patient information sheet

Condition

Marternal and child health

Intervention

We will evaluate association between price and adoption decisions 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, California (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Freeman Spogli Institute, Stanford University, California (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Duke University, North Carolina (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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