Newborn Thermal Care Practices: A Community Based Program to Prevent Hypothermia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00198653
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : May 7, 2007
Information provided by:
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
The purpose of this study is to train mothers/caretakers on how to prevent their babies from becoming too cold.

Condition or disease Intervention/treatment Phase
Hypothermia Behavioral: Newborn Thermal Care Practice Not Applicable

Detailed Description:
This study is designed to determine domiciliary care knowledge, attitudes and practices regarding essential newborn care, with a focus on newborn thermal control; develop behavior change communications to promote prevention, early recognition and effective management of newborn hypothermia, evaluate impact and cost-effectiveness of education/behavior change communications delivered by Community Health Workers and Community Health Promoters/Change Agents on essential newborn care practices, including care-seeking; prevalence, recognition and management of hypothermia, including adaptation, safety and utility of Kangaroo Mother Care; and neonatal morbidity and mortality; evaluate the feasibility and acceptability of using LCT ThermoSpot device in rural communities to enhance mothers' recognition and management of neonatal hypothermia; determine the influence of the neonatal hypothermia indicator (ThermoSpot) on recognition of and response to newborn hypothermia and health-seeking behavior of the caregivers; develop algorithms for recognition and management of hypothermia to inform neonatal IMCI and verbal autopsy protocols and gain insight into the potential roles of various cadres of workers in providing neonatal health services at the community level and inform the development of models of community-based essential newborn care.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Newborn Thermal Care Practices in Rural India: A Community Based Program to Prevent and Improve Recognition and Management of Hypothermia
Study Start Date : March 2003
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Uttar Pradesh
  • Newborns at home

Exclusion Criteria:

  • Hospitalized babies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00198653

CSMMU at Lucknow; King Georges Medical College
Lucknow, Uttar Pradesh, India
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Gary Darmstadt, MD Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00198653     History of Changes
Other Study ID Numbers: H.
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 7, 2007
Last Verified: April 2007

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Maternal/Child Health
Kangaroo Mother Care

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms