Intervening to Improve Infant Health in Ghana

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

$100Kitchen and Low-birth-weight Study in Rural Bangladesh

NCT02923882

Pregnant Women Low-Birth-Weight Infant

COMPLETED PHASE2

Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

NCT00786877

Acute Lower Respiratory Illness

COMPLETED PHASE3

Household Air Pollution and Health: A Multi-country LPG Intervention Trial

NCT02944682

Infant, Low Birth Weight

COMPLETED NA

Household Air Pollution and Pregnancy Outcome

NCT02394574

Pregnancy

COMPLETED NA

Tobacco Smoke and Lead Exposure During Pregnancy

NCT00514280

Lead Exposure in Pregnant Women Tobacco Smoke Exposure Pregnant Women

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Very Low Birth Weight Baby Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel

Intervention Type OTHER

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes