Community-Based Interventions for Infant Health in Nepal

This study is currently recruiting participants.

Verified by Institute of Child Health, April 2008

Sponsored by:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00656591

Purpose

An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal & Infant Mortality and to Improve Fetal Growth & Cognitive Development in Infancy

Condition	Intervention	Phase
Child Mortality	Drug: Methotrexate	Phase I

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Prospective
Official Title:	An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal and Infant Mortality, and to Improve Fetal Growth and Cognitive Development in Infancy.

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:

neonatal mortality rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	192000
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Methotrexate

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

48 village development committee areas

Criteria

Inclusion Criteria:

mothers, community health volunteers

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656591

Locations

United Kingdom
International Child Health, ICH	Recruiting
London, United Kingdom, WC1N 1EH
Contact: Anthony Costello, Dr a.costello@ich.ucl.ac.uk

Sponsors and Collaborators

Institute of Child Health

Investigators

Principal Investigator:

Anthony Costello, Dr

Institute of Child Health

More Information

Responsible Party:	Institute of Child Health ( R&D Office )
Study ID Numbers:	04PC01
Study First Received:	December 22, 2006
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00656591
Health Authority:	United Kingdom: National Health Service; United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:

Child mortality, Nepal, Community, care practices

Study placed in the following topic categories:

Folic Acid
Methotrexate

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal

Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009