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Newborn Thermal Care Practices: A Community Based Program to Prevent Hypothermia
This study has been terminated.
Sponsored by: Johns Hopkins Bloomberg School of Public Health
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00198653
  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

MedlinePlus related topics: Hypothermia
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Newborn Thermal Care Practices in Rural India: A Community Based Program to Prevent and Improve Recognition and Management of Hypothermia

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Uttar Pradesh
  • Newborns at home

Exclusion Criteria:

  • Hospitalized babies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 indexed to this study:
Study ID Numbers: H.22.02.07.15.A1
Study First Received: September 12, 2005
Last Updated: May 3, 2007
ClinicalTrials.gov Identifier: NCT00198653  
Health Authority: India: Office of Research and Ethics Review Committee;   United States: Institutional Review Board

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

Study placed in the following topic categories:
Signs and Symptoms
Hypothermia

Additional relevant MeSH terms:
Body Temperature Changes

ClinicalTrials.gov processed this record on January 15, 2009