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NCT00198653 Clinical Trial

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

Hypothermia Clinical Trial

Official title:
Newborn Thermal Care Practices in Rural India: A Community Based Program to Prevent and Improve Recognition and Management of Hypothermia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00198653
Other study ID # H.22.02.07.15.A1
Secondary ID
Status Terminated
Phase N/A
First received September 12, 2005
Last updated May 3, 2007
Start date March 2003
Est. completion date October 2006

Study information
Verified date April 2007
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority India: Office of Research and Ethics Review CommitteeUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Uttar Pradesh

- Newborns at home

Exclusion Criteria:

- Hospitalized babies

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Newborn Thermal Care Practice

Locations
Country Name City State
India CSMMU at Lucknow; King Georges Medical College Lucknow, Uttar Pradesh

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

India, 

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