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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]

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

Stillbirth

Early neonatal mortality

Low birthweight

Preterm birth

Neonatal death

Stunting at age 2

child growth

diarrhoea

death

developmental delay

acute respiratory illness

Condition category

Condition code

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

Perinatal mortality (defined as stillbirth less than 28 weeks and early neonatal death less than or equal to 7 days after birth)

Timepoint [1]

After birth, and within 48 hours post-partum

Primary outcome [2]

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]

Age 2

Secondary outcome [1]

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]

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]

Number of babies born with low birth weight (less than 2500grams)

Timepoint [2]

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]

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]

Up to 48 hours after the birth, collected from the participant by the field staff.

Secondary outcome [4]

Early neonatal death (death of a live born infant from birth to less than or equal to 7 days after birth)

Timepoint [4]

Up to 35 days after the birth

Secondary outcome [5]

Neonatal death (death of a live born infant from birth to equal to 28 days after birth)

Timepoint [5]

Up to 35 days after birth

Secondary outcome [6]

Satisfaction with the LPG stoves

Timepoint [6]

Up to 35 days after the birth from each participant using a likert scale

Secondary outcome [7]

Acceptability of the LPG stoves using a likert scale

Timepoint [7]

Up to 35 days after the birth

Secondary outcome [8]

Stove use (per cent of cooking time with LPG stove during the intervention period).

Timepoint [8]

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?

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]

Bangladesh

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney,
NSW 2206

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ICDDr, B Ethics Review Committee

Ethics committee address [1]

68, Shaheed Tajuddin Ahmed Sarani

Mohakhali, Dhaka 1212, Bangladesh

Ethics committee country [1]

Bangladesh

Date submitted for ethics approval [1]

06/08/2017

Approval date [1]

23/01/2018

Ethics approval number [1]

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

Prof Camille Raynes-Greenow

Address

Edward Ford Building (A27)
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9351 5308

Fax

camille.raynes-greenow@sydney.edu.au

Contact person for public queries

Name

Camille Raynes-Greenow

Address

Edward Ford Building (A27)
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 93515308

Fax

camille.raynes-greenow@sydney.edu.au

Contact person for scientific queries

Name

Camille Raynes-Greenow

Address

Edward Ford Building (A27)
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9351 5308

Fax

camille.raynes-greenow@sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Protocol 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.	2022	https://dx.doi.org/10.1186/s13063-022-06146-7
Embase	Reducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the "Poriborton-Extension: The CHANge trial".	2022	https://dx.doi.org/10.1186/s13063-022-06342-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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