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

Primary Purpose

Hypothermia

Status

Terminated

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Newborn Thermal Care Practice

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring Hypothermia, Newborn, India, Maternal/Child Health, Infant, Kangaroo Mother Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Uttar Pradesh Newborns at home Exclusion Criteria: Hospitalized babies

Sites / Locations

CSMMU at Lucknow; King Georges Medical College

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00198653

First Posted

September 12, 2005

Last Updated

May 3, 2007

Sponsor

Johns Hopkins Bloomberg School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT00198653

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Terminated

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothermia

Keywords

Hypothermia, Newborn, India, Maternal/Child Health, Infant, Kangaroo Mother Care

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Newborn Thermal Care Practice

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Uttar Pradesh Newborns at home Exclusion Criteria: Hospitalized babies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Darmstadt, MD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

CSMMU at Lucknow; King Georges Medical College

City

Lucknow, Uttar Pradesh

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

18926277

Citation

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. doi: 10.1016/S0140-6736(08)61483-X.

Results Reference

derived

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

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