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Trial registered on ANZCTR


Registration number
ACTRN12618001214224
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
19/07/2018
Date last updated
2/06/2023
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Poriborton : Change trial: Household Air Pollution and Perinatal and early Neonatal mortality.
Scientific title
A cluster randomised controlled trial of LPG cookstoves and gas commenced in early pregnancy and continued throughout to reduce perinatal mortality. The Poriborton: Change Trial
Secondary ID [1] 290589 0
None
Universal Trial Number (UTN)
U1111-1190-1483
Trial acronym
Poriborton: The Change Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal mortality 301051 0
Stillbirth 301056 0
Early neonatal mortality 301057 0
Low birthweight 301058 0
Preterm birth 301060 0
Neonatal death 301061 0
Stunting at age 2 322500 0
child growth 322501 0
diarrhoea 322502 0
death 322503 0
developmental delay 322504 0
acute respiratory illness 322505 0
Condition category
Condition code
Reproductive Health and Childbirth 300838 300838 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Liquid Petroleum Gas (LPG) two-burner stove and LPG fuel in cylinders will be delivered to participants soon after enrolment. This will include initial set-up and connection.
Adoption of LPG cooking will be supported by behaviour change communication (BCC) from field staff who will visit participants homes monthly, for about an hour during pregnancy until the birth. LPG gas in cylinders will be replenished as needed to ensure continuous LPG supply until the birth.
The BCC material will include a pictorial leaflet, short video's shown to participants during the monthly visits on tablets, and verbal messages to help support adoption of LPG cooking, and tips for trouble shooting with LPG cooking (if any). This material is based on the formative research done for this trial.

Field staff will be trained in delivering the BCC material at three time points throughout the intervention period to ensure consistency of the messages. Training will be a 2 day sessions conducted by senior research staff, who will teach the field staff how to deliver to the messages about continual gas use, and how to overcome LPG difficulties.


Intervention code [1] 296454 0
Prevention
Intervention code [2] 296455 0
Lifestyle
Comparator / control treatment
Usual cooking practices, include a mix of traditional and modern cooking practices and fuels. Traditional cooking practices include a small home-built mud or clay burner, that sits on the ground either inside the home or outside. It does not have a chimney and usually only has one fuel feeder at the front in which fuel is inserted and lit. It also usually only has one pot rest. Fuel can include almost anything that burns including sticks and bark collected locally, dried cow dung, and/or crop waste. In some homes, families may also use modern fuels such as LPG, or kerosene, and modern burners - but in the study area this is very rare.
Control group
Active

Outcomes
Primary outcome [1] 306543 0
Perinatal mortality (defined as stillbirth less than 28 weeks and early neonatal death less than or equal to 7 days after birth)
Timepoint [1] 306543 0
After birth, and within 48 hours post-partum
Primary outcome [2] 328016 0
Changes in the percentage of stunted children (height-for-age <-2 SD Z score) at 24 months in a sub-group of enrolled participants. Using the WHO Child Growth Standards.
Timepoint [2] 328016 0
Age 2
Secondary outcome [1] 349272 0
Cost effectiveness in reducing perinatal mortality and morbidity (costs to deliver the whole intervention, and estimates of incremental cost per life year saved).
Timepoint [1] 349272 0
Collected up to 35 days after birth. Any health costs will be collected from participants. Costs for the intervention will be collected from our own records.
Secondary outcome [2] 349375 0
Number of babies born with low birth weight (less than 2500grams)
Timepoint [2] 349375 0
Up to 48 hours after the birth, collected from the participants. For those who give birth at home we will weigh the infant. For hospital births we will collect the weight from the participant.
Secondary outcome [3] 349376 0
Preterm birth (birth before 37 completed weeks gestation, or in the absence of gestation birth weight <2500grams, or in absence of measured birth weight 'small birth size')
Timepoint [3] 349376 0
Up to 48 hours after the birth, collected from the participant by the field staff.
Secondary outcome [4] 349377 0
Early neonatal death (death of a live born infant from birth to less than or equal to 7 days after birth)
Timepoint [4] 349377 0
Up to 35 days after the birth
Secondary outcome [5] 349378 0
Neonatal death (death of a live born infant from birth to equal to 28 days after birth)
Timepoint [5] 349378 0
Up to 35 days after birth
Secondary outcome [6] 349379 0
Satisfaction with the LPG stoves
Timepoint [6] 349379 0
Up to 35 days after the birth from each participant using a likert scale
Secondary outcome [7] 349380 0
Acceptability of the LPG stoves using a likert scale
Timepoint [7] 349380 0
Up to 35 days after the birth
Secondary outcome [8] 349382 0
Stove use (per cent of cooking time with LPG stove during the intervention period).
Timepoint [8] 349382 0
Up to 48 hours after birth, based on participants estimates of per cent of cooking time spent on cooking on each stove

Eligibility
Key inclusion criteria
Inclusion criteria for participants
• All newly identified pregnant women aged 15 to 49 years
• Gestational age is less than or equal to 20 weeks and are
• Permanent residents of the study area.
For the trial extension inclusion criteria:
currently enrolled women with a live infant, < 90 days post-partum
Minimum age
15 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants
• Woman could not recall last menstrual period (LMP)
• Woman not a permanent resident of the study area

Exclusion criteria for clusters
• Cookstove interventions currently being implemented by either government or non-government agencies in the selected area
• Area it is prone to flooding for extended periods, which would impede access by the research team

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster design
Data collectors masked for outcome
The intervention will be distributed at the individual level, but randomised at the cluster level. This is to assist adoption of clean cooking practices at the community level. The outcome assessments will also be at the individual level. Pregnant women and their households will receive the intervention based on their cluster of residence.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We calculated the sample size based on the primary outcome, a lower rate of perinatal mortality in the intervention arm compared to the usual cooking arm. A recent analysis of polluting vs. clean fuels estimates an elevated risk of perinatal mortality at 56% (aRR1.44, (95%CI 1.30, 1.61). We have therefore based our sample size on a conservative estimate that was informed by these studies. We anticipate a 36% reduction in the LPG arm. The following assumptions are used for sample size calculation:
• The cluster size with an average population of 12,700.
• Expected (rural) crude birth rate is 23/1000 population per 12 months, which would give an average expected 219 births over 9 months’ enrolment period.
• Conservative estimate of pregnancy identification at ~85% of all pregnancies occurred in selected clusters, through an active surveillance of currently married women in reproductive age by project staff, giving ~186 pregnancies identified per cluster over 9 months.
• 95% participation based on Shonjibon Trial (PR-11074) recruitment which would yield 177 pregnant women available to be enrolled per cluster over 9 months.
• Based on the Shonjibon Trial (PR-11074), 10% of pregnancy loss (abortion/miss carriage, loss to follow up) and another 5% of women would deliver outside the study area, thus leaving an expected 150 births per cluster
• Perinatal mortality is expected to be 50 per 1000 pregnancies in control clusters based on the estimates from Shonjibon Trial (ACTRN12612000588897).
• 90% power and 5% two-sided alpha
• The published intra-class correlations (ICC) for stillbirth and neonatal mortality in rural Bangladesh are very low, 0.00055, and 0.00000 respectively. We thus used a conservative ICC of 0.00075.
We will conduct an intention-to-treat analysis, and outcomes will be assessed at the individual level. Baseline characteristics will be summarised to assess for balance of key variables. Our analysis plan is as follows
1) Conduct the primary analysis of the improved cook-stove compared to the usual cook-stove for perinatal mortality
2) Compare the LPG arm to the control arm for perinatal mortality
3) Compare the ICS or LPG arms individually, to the control arm, for perinatal morbidity, preterm birth, and low birth weight.
Data anlaysis
We will estimate relative risks and 95% confidence using generalized estimating equations (GEE) logistic binomial regression models, a log link function, and exchangeable correlation. The intervention will be a fixed effect, and the cluster as a random effect to account for clustering. We will do separate models for our specified outcomes. To ensure we only detect potentially important interactions with the mortality outcomes we will enhance power (P <0.10 (vs <0.05)) in the GEE logistic regression models.
For exposure data we will calculate exposure-response functions for different exposure metrics, by using a two-stage approach, first graphical summaries (e.g., loess plots) to examine the shape of the relationship of the exposure metrics to the outcome. For this initial exploratory stage we will also use standard multivariate approaches (e.g. principal components, spectral decompositions) to reduce the dimensionality of high-dimensional metrics. Real-time measurements of PM 2.5 and CO will allow us to explore which summary metrics (e.g., integrated total mass exposure, peak exposure levels, time above risk threshold) are most closely associated with the outcome. Based on the exploratory analyses, we will then use appropriate generalized linear models to generate estimates of the effect of the exposure metrics (or combinations of) on the outcomes. For all analyses, effect sizes and 95% confidence intervals will be calculated, and the exact P-value will be presented.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/09/2019
Actual
24/09/2019
Date of last participant enrolment
Anticipated
30/04/2021
Actual
7/06/2021
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
4944
Accrual to date
Final
4944
Recruitment outside Australia
Country [1] 10622 0
Bangladesh
State/province [1] 10622 0

Funding & Sponsors
Funding source category [1] 299975 0
Government body
Name [1] 299975 0
NHMRC
Country [1] 299975 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
NSW 2206
Country
Australia
Secondary sponsor category [1] 309887 0
None
Name [1] 309887 0
Address [1] 309887 0
Country [1] 309887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300833 0
ICDDr, B Ethics Review Committee
Ethics committee address [1] 300833 0
68, Shaheed Tajuddin Ahmed Sarani

Mohakhali, Dhaka 1212, Bangladesh
Ethics committee country [1] 300833 0
Bangladesh
Date submitted for ethics approval [1] 300833 0
06/08/2017
Approval date [1] 300833 0
23/01/2018
Ethics approval number [1] 300833 0
PR - 17103

Summary
Brief summary
Globally, household air pollution (HAP) is the 3rd leading health risk for mortality, and the most important global environmental health risk (1). The South Asian burden is acute, and it is their most considered health risk (1). The global mortality attributable to HAP is 4.3 million deaths or 7.7% of all deaths (1). Approximately, 3 billion people depend on biomass fuels (e.g. wood, dung, crop waste), and this combined with incomplete combustion using inefficient stoves, in poorly ventilated areas, over long hours of cooking and heating, causes the exposure with women and children bearing the greatest burden, and being particularly vulnerable (2, 3). The impact on pregnancy is unknown. The epidemiological evidence is suggestive of an association, however, there is a paucity of good quality prospective data (4).

Perinatal mortality (defined as stillbirth less than 28 weeks and early neonatal death up to and equal to 7 days after birth) is recognized as a major global health disease burden. The global burden of Stillbirth is high with ~2.6 million stillbirths per year (5), and stillbirth estimates in Bangladesh are high at 35 per 1000, and are worse in rural areas (6,7), where there is universal reliance on polluting usual stoves (8,9).

We propose to conduct a community based cluster randomized trial to explore the effectiveness and cost effectiveness of cleaner cooking (LPG and ICS) in preventing adverse perinatal outcomes. This trial is needed as it will address several important gaps of the impact of HAP and the impact on pregnancy outcomes.
REFERENCES
1. Lim, S.S.etal., A comparative risk assessment of burden of disease …a systematic analysis for the Global Burden of Disease Study 2010.Lancet, 2012. 380(9859): p. 2224-60.
2. Fullerton, D.G.etal., Indoor air pollution from biomass fuel smoke is a major health concern in the developing world. Royal Society of Trop Med Hyg, 2008. 102(9): p. 843.
3. WHO, Indoor Air Poll from Solid Fuels and risk of low birth weight and stillbirth. 2005.
4. Tielsch, J.M.etal., Exposure to indoor biomass fuel and tobacco smoke and risk of adverse reproductive outcomes, International Journal of Epidemiology, 2009. 38(5): p. 1351-1363.
5. Rehfuess, E., Fuel for life - household energy and health.World Health Organization, 2006.
6.United Nations., The Millennium Development Goals Report. 2014: New York.
7. Lawn, J.E. Stillbirths: rates, risk factors, and accelerating towards 2030. Lancet, 2016. 387: 587.
8. UNICEF., Levels and Trends in Child Mortality. 2014, UNICEF.
9. Lawn, J.E.etal., 4 million neo… deaths:When? Where? Why? Lancet, 2005. 365(9462): 891.
Trial website
none
Trial related presentations / publications
Public notes
Facebook page https://www.facebook.com/HAPPeNTrial/

Crowd funding page: https://crowdfunding.sydney.edu.au/project/10578

Contacts
Principal investigator
Name 70642 0
Prof Camille Raynes-Greenow
Address 70642 0
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 70642 0
Australia
Phone 70642 0
+61 2 9351 5308
Fax 70642 0
Email 70642 0
[email protected]
Contact person for public queries
Name 70643 0
Camille Raynes-Greenow
Address 70643 0
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 70643 0
Australia
Phone 70643 0
+61 2 93515308
Fax 70643 0
Email 70643 0
[email protected]
Contact person for scientific queries
Name 70644 0
Camille Raynes-Greenow
Address 70644 0
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 70644 0
Australia
Phone 70644 0
+61 2 9351 5308
Fax 70644 0
Email 70644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be available for consideration for sharing
When will data be available (start and end dates)?
We propose to release data in 2025, with no end date
Available to whom?
All cases will be considered but applicants will need to provide a methodologically sound proposal.
Available for what types of analyses?
Purposes to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator, with requirements to sign data access agreement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a cluster randomised controlled trial of LPG cookstoves compared to usual cooking practices to reduce perinatal mortality and morbidity in rural Bangladesh called Poriborton: the CHANge trial.2022https://dx.doi.org/10.1186/s13063-022-06146-7
EmbaseReducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the "Poriborton-Extension: The CHANge trial".2022https://dx.doi.org/10.1186/s13063-022-06342-5
N.B. These documents automatically identified may not have been verified by the study sponsor.