Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00198653
First received: September 12, 2005
Last updated: May 3, 2007
Last verified: April 2007

September 12, 2005
May 3, 2007
March 2003
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00198653 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Newborn Thermal Care Practices: A Community Based Program to Prevent Hypothermia
Newborn Thermal Care Practices in Rural India: A Community Based Program to Prevent and Improve Recognition and Management of Hypothermia

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypothermia
Behavioral: Newborn Thermal Care Practice
Not Provided
Kumar V, Mohanty S, Kumar A, Misra RP, Santosham M, Awasthi S, Baqui AH, Singh P, Singh V, Ahuja RC, Singh JV, Malik GK, Ahmed S, Black RE, Bhandari M, Darmstadt GL; Saksham Study Group. Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial. Lancet. 2008 Sep 27;372(9644):1151-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
October 2006
Not Provided

Inclusion Criteria:

  • Uttar Pradesh
  • Newborns at home

Exclusion Criteria:

  • Hospitalized babies
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00198653
H.22.02.07.15.A1
Not Provided
Not Provided
Johns Hopkins Bloomberg School of Public Health
Not Provided
Principal Investigator: Gary Darmstadt, MD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP