Intervening to Improve Infant Health in Ghana

This study is not yet open for participant recruitment.

Verified November 2012 by Columbia University

Sponsor:

Collaborator:

National Institute of Environmental Health Sciences (NIEHS)

Information provided by (Responsible Party):

Columbia University

ClinicalTrials.gov Identifier:

NCT01335490

First received: April 13, 2011

Last updated: November 13, 2012

Last verified: November 2012

History of Changes

Purpose

The purpose of the study is to understand how cooking might affect the health of pregnant women and their babies.

The goal of the research is to determine whether, interventions in decreasing exposure to smoke from cook stoves can bring about a significant change in the indoor air pollution levels and health of communities in Ghana.

Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead to a significant increase in average birth weight in newborns.

Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of severe acute lower respiratory disease during the first six months of life.

Condition	Intervention
Very Low Birth Weight Baby Acute Lower Respiratory Disease	Other: Cook stove

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Intervening to Improve Birth Weight and Infant Respiratory Health in Rural Ghana

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Low birth weight [ Time Frame: Birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute lower respiratory disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	890
Study Start Date:	November 2012
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cook stove	Other: Cook stove The cooking stove will reduce air emissions significantly in the home. It will be given to the mother in the third trimester.
No Intervention: No cook stove

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Sign informed consent form
Subject must be of African decent
Subject must be pregnant
Subject must be willing to participate in all visits and study procedures

Exclusion Criteria:

At time of screening, more than 28 weeks gestation
Subject is not pregnant
Subject is carrying more than one fetus
Subject is carrying a fetus that is no longer living

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335490

Contacts

Contact: Darby Jack, PhD

212-305-1692

dj2183@columbia.edu

Locations

United States, New York
Columbia University Medical Center	Not yet recruiting
New York, New York, United States, 10032
Contact: Darby Jack, PhD 212-305-1692 dj2183@columbia.edu
Principal Investigator: Patrick Kinney, ScD
Sub-Investigator: Darby Jack, PhD
Ghana
Kintampo Medical Research Center	Not yet recruiting
Kintampo, Ghana
Principal Investigator: Seth Owusu-Agyei
Sub-Investigator: Kwaku P. Asante

Sponsors and Collaborators

Columbia University

National Institute of Environmental Health Sciences (NIEHS)

Investigators

Principal Investigator:

Patrick Kinney, ScD

Columbia University

More Information

No publications provided

Responsible Party:	Columbia University
ClinicalTrials.gov Identifier:	NCT01335490 History of Changes
Other Study ID Numbers:	AAAF3520, 1R01ES019547-01A1
Study First Received:	April 13, 2011
Last Updated:	November 13, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Birth Weight
Respiration Disorders
Respiratory Tract Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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