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Sponsored by: |
Johns Hopkins Bloomberg School of Public Health |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00198653 |
The purpose of this study is to train mothers/caretakers on how to prevent their babies from becoming too cold.
Condition | Intervention |
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Hypothermia |
Behavioral: Newborn Thermal Care Practice |
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 |
Study Start Date: | March 2003 |
Study Completion Date: | October 2006 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India | |
CSMMU at Lucknow; King Georges Medical College | |
Lucknow, Uttar Pradesh, India |
Principal Investigator: | Gary Darmstadt, MD | Johns Hopkins Bloomberg School of Public Health |
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 |
Hypothermia Newborn India |
Maternal/Child Health Infant Kangaroo Mother Care |
Signs and Symptoms Hypothermia |
Body Temperature Changes |