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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00198653
First Posted: September 20, 2005
Last Update Posted: May 7, 2007
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.
Information provided by:
Johns Hopkins Bloomberg School of Public Health
  Purpose
The purpose of this study is to train mothers/caretakers on how to prevent their babies from becoming too cold.

Condition Intervention
Hypothermia Behavioral: Newborn Thermal Care Practice

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Study Start Date: March 2003
Study Completion Date: October 2006
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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Uttar Pradesh
  • Newborns at home

Exclusion Criteria:

  • Hospitalized babies
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00198653


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00198653     History of Changes
Other Study ID Numbers: H.22.02.07.15.A1
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: May 7, 2007
Last Verified: April 2007

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

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms