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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypothermia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Newborn Thermal Care Practice

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Uttar Pradesh
* Newborns at home

Exclusion Criteria

* Hospitalized babies

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Gary Darmstadt, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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CSMMU at Lucknow; King Georges Medical College

Lucknow, Uttar Pradesh, , India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED

PMID: 18926277 (View on PubMed)

Other Identifiers

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H.22.02.07.15.A1

Identifier Type: -

Identifier Source: org_study_id