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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT02944682 |
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Date of registration:
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17/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Household Air Pollution and Health: A Multi-country LPG Intervention Trial
HAPIN |
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Scientific title:
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Household Air Pollution and Health: A Multi-country LPG Intervention Trial |
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Date of first enrolment:
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September 1, 2017 |
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Target sample size:
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3640 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02944682 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Guatemala
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India
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Peru
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Rwanda
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United Kingdom
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United States
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Contacts
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Name:
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Thomas Clasen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Name:
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William Checkley, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins School of Medicine |
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Name:
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Jennifer Peel, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Colorado State University |
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Key inclusion & exclusion criteria
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Inclusion Criteria for Pregnant Women:
- Confirmed pregnancy (hCG positive blood or urine test)
- Aged 18 to <35 years (via self-report)
- Uses biomass stove predominantly
- Lives in study area
- 9 - <20 weeks gestation confirmed by ultrasound
- Singleton pregnancy (one fetus)
- Viable fetus with normal fetal heart rate (120-180 beats per minute) at time of
ultrasound
- Continued pregnancy at the time of randomization confirmed by self-report
- Agrees to participate with informed consent
Exclusion Criteria for Pregnant Women:
- Currently smokes cigarettes or other tobacco products
- Plans to move permanently outside study area in the next 12 months
- Uses LPG stove predominantly, or is likely to use LPG predominantly in the near future
Inclusion Criteria for Older Adult Woman in the Same Household:
- Aged 40 to <80 years (via self-report)
Exclusion Criteria for Older Adult Woman in the Same Household:
- Currently smokes cigarettes or other tobacco products
- Pregnant (by self-report)
- Plans to move out of her current household in the next 12 months
Age minimum:
18 Years
Age maximum:
79 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infant, Low Birth Weight
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Intervention(s)
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Other: Liquefied petroleum gas (LPG) cookstove
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Primary Outcome(s)
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Change in Caregiver Reported Early Childhood Development Instrument (CREDI) Score
[Time Frame: 3 months of age to 24 months of age]
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Incidence of HAPIN Defined Severe Pneumonia
[Time Frame: Up to 12 months after birth]
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Change in Systolic Blood Pressure
[Time Frame: Baseline, 3, 5, 9, 12, and 18 months post-randomization, 24, 36, 48, and 60 months of age]
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Length-for-age z-score 2 standard deviations below the standard
[Time Frame: 12 months after birth]
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Birth weight
[Time Frame: Within 24 hours of birth (up to 5 months post-randomization of mother)]
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Change in Malawi Developmental Assessment Tool (MDAT) Score
[Time Frame: 36, 48 and 60 months of age]
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Change in Child Linear Growth
[Time Frame: Birth (3-5 months post-randomization), 3, 6, 9, 12, 24, 36, 48 and 60 months of age]
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Secondary Outcome(s)
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Hospitalization for respiratory illness
[Time Frame: Up to 12 months after birth]
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WHO Pocket Book Severe Pneumonia
[Time Frame: Up to 12 months after birth]
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Change in Carotid intima-media thickness (CIMT)
[Time Frame: Baseline, 18 months post-randomization, and when child is 24 months of age]
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Death
[Time Frame: Up to Study Exit (up to 60 months of age of child)]
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Fetal Growth
[Time Frame: Baseline, Gestation Week 24-28 and Gestation Week 32-36]
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Hypoxemic Pneumonia
[Time Frame: Up to 12 months after birth]
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Change in Diastolic blood pressure
[Time Frame: Baseline, 3, 6, 12 and 18 months post-randomization, 24, 36, 48, and 60 months of age]
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Change in Maternal Blood Pressure
[Time Frame: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation, 24, 36, 48 and 60 months of age]
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Mean arterial pressure
[Time Frame: Baseline, 3, 6, 12 and 18 months post-randomization, 24, 36, 48, and 60 months of age]
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Pulse pressure
[Time Frame: Baseline, 3, 6, 12 and 18 months post-randomization, 24, 36, 48, and 60 months of age]
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WHO Non-severe Pneumonia
[Time Frame: Up to 12 months after birth]
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Change in Dried Blood Spot (DBS) Biomarkers
[Time Frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, 3, 6, 12 and 24 months of age]
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Change in Height
[Time Frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, 24 months of age]
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Child Lung Function
[Time Frame: 36, 48 and 60 months of age]
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Preterm birth
[Time Frame: Up to 5 months (within 24 hours of birth, 3-5 months post randomization)]
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Change in Body Mass Index (BMI)
[Time Frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, 24, 36, 48 and 60 months of age]
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Change in Brachial artery reactivity testing (BART)
[Time Frame: Baseline, 18 months]
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Change in Urinary Biomarkers
[Time Frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, 3, 6, 12 and 24 months of age]
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Gestational age at birth
[Time Frame: Up to 5 months (within 24 hours of birth, 3-5 months post randomization)]
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Change in Short Form 36 Survey (SF-36) Score
[Time Frame: Baseline, 18 months]
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Change in St. George Respiratory Questionnaire (SGRQ) Score
[Time Frame: Baseline, 18 months]
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Change in Weight
[Time Frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, 24, 36, 48 and 60 months of age]
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Ultrasound or Radiograph Pneumonia
[Time Frame: Up to 12 months after birth]
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WHO Pocket Book Non-severe Pneumonia
[Time Frame: Up to 12 months after birth]
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WHO Severe Pneumonia
[Time Frame: Up to 12 months after birth]
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Secondary ID(s)
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1UM1HL134590-01
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IRB00089799
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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