NCT00198653

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 7, 2007

Status Verified

April 1, 2007

First QC Date

September 12, 2005

Last Update Submit

May 3, 2007

Conditions

Hypothermia

Keywords

HypothermiaNewbornIndiaMaternal/Child HealthInfantKangaroo Mother Care

Interventions

Newborn Thermal Care PracticeBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uttar Pradesh
  • Newborns at home

You may not qualify if:

  • Hospitalized babies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSMMU at Lucknow; King Georges Medical College

Lucknow, Uttar Pradesh, India

Location

Related Publications (1)

  • 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.

    PMID: 18926277DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gary Darmstadt, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2003

Study Completion

October 1, 2006

Last Updated

May 7, 2007

Record last verified: 2007-04

Locations

IN(1)