Intervening to Improve Infant Health in Ghana

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Columbia University
Sponsor:
Collaborators:
Global Alliance for Clean Cook Stoves
Thrasher Research Fund
Information provided by (Responsible Party):
Patrick L. Kinney, Columbia University
ClinicalTrials.gov Identifier:
NCT01335490
First received: April 13, 2011
Last updated: September 29, 2014
Last verified: September 2014
  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 stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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: 1415
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
Experimental: Biolite Cook Stove
Provision of two cook stoves to each subject. Each stove burns wood fuel, but more efficiently than a traditional three stone fire.
Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel
The cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester.
Experimental: LPG Cook Stove
Provision of a two-burner liquified petroleum gas stove to each subject, along with fuel needed for the family during the follow up period.
Other: Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel
The cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester.
No Intervention: Control

Detailed Description:

2. Overview of design and analysis [per CONSORT 2010] 2.1 Trial design [CONSORT 3a] The study is a three-arm cluster randomized trial, with two intervention arms and a control arm. The primary justification for intervening at the village level is that an individual level randomization, which would entail treatments and controls living side-by-side in a village, could lead to conflict within villages.

2.2 Study Participants [CONSORT 4a, 4b] The study will take place in the catchment area of Kintampo Health Research Centre. This comprises a population of 146,000. The study population is primarily rural and agricultural, and cooks primarily with biomass fuels. The study area is well described in Owusu-Agyei et al. 2012 (38).

A cluster was eligible to participate if it:

  • Is located in Kintampo North or South Districts (this is the core study area for KHRC)
  • Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
  • Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
  • Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).

A woman will be eligible to participate in the study if she:

  • Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
  • Is carrying a live singleton fetus (twins will be excluded)
  • Is the primary cook in her household or compound; and
  • Is a non-smoker. 2.3 Interventions [CONSORT 5]

The study has three arms:

  1. LPG intervention arm, in which households receive a two burner LPG cookstove and monthly gas deliveries;
  2. An efficient biomass arm, in which households receive two BioLite cookstoves; and
  3. A control arm 2.4 Outcomes [CONSORT 6a]

The primary health outcome measures for the study are:

  1. Infant weight at birth, and
  2. Physician assessed pneumonia. Baseline assessments of outcomes No baseline data for ALRI prevalence from Ghana is available. Our study will thus provide very valuable baseline data regarding this important disease.

KHRC has, in the course of conducting other research projects, captured some information regarding birth weight; statistics calculated from these data were used as inputs into power calculations. These data are described in (39).

2.5 Sample size [CONSORT 7a, 7b] For the three-arm design, we calculate that we need to enroll households to achieve our target of 1225 births (assuming that 85% of the pregnancies will result in a recorded birth after, accounting for move out, drop out, and still birth rates). These will be spread across 35 or more clusters, as outlined in the following table.

Clusters Births Enrollment BioLite 13 455 525 Control 13 455 525 LPG 9 315 365 total 35 1225 1415

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

A cluster was eligible to participate if it:

  • Is located in Kintampo North or South Districts (this is the core study area for KHRC)
  • Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people);
  • Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges);
  • Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries).

A woman will be eligible to participate in the study if she:

  • Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks)
  • Is carrying a live singleton fetus (twins will be excluded)
  • Is the primary cook in her household or compound; and
  • Is a non-smoker.
  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 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 Recruiting
Kintampo, Ghana
Principal Investigator: Seth Owusu-Agyei         
Sub-Investigator: Kwaku P. Asante         
Sponsors and Collaborators
Columbia University
Global Alliance for Clean Cook Stoves
Thrasher Research Fund
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: September 29, 2014
Health Authority: United States: Institutional Review Board
Ghana: Kintampo Health Research Center Ethics Review Board

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014