Intervening to Improve Infant Health in Ghana

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patrick L. Kinney, Columbia University
ClinicalTrials.gov Identifier:
NCT01335490
First received: April 13, 2011
Last updated: July 25, 2013
Last verified: July 2013
  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 12 months of life.


Condition Intervention
Very Low Birth Weight Baby
Pneumonia
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:


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: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 890
Study Start Date: August 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 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 primary cook in the household or compound
  • Subject must be a non-smoker
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Patrick Kinney, ScD Columbia University
  More Information

No publications provided

Responsible Party: Patrick L. Kinney, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01335490     History of Changes
Other Study ID Numbers: AAAF3520, 1R01ES019547-01A1
Study First Received: April 13, 2011
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Birth Weight
Pneumonia
Body Weight
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 28, 2014