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Abstract
Introduction Multiple cohort studies have been established to investigate the impact of early life factors on development and health outcomes. In Australia the majority of these studies were established more than 20 years ago and, although longitudinal in nature, are inherently susceptible to socioeconomic, environmental and cultural influences which change over time. Additionally, rapid leaps in technology have increased our understanding of the complex role of gene–environment interactions in life course health, highlighting the need for new cohort studies with repeated biological sampling and in-depth phenotype data across the first 1000 days of life from conception.
Methods and analysis The Newcastle 1000 (NEW1000) Study, based in the regional city of Newcastle, New South Wales, was developed after an extensive consultation process involving 3 years of discussion with key stakeholders and healthcare consumer organisations and seven healthcare consumer workshops. This prospective population-based pregnancy cohort study will recruit 500 families per year for 5 years, providing detailed, longitudinal, multisystem phenotyping, repeated ultrasound measures and serial sample collection to investigate healthcare consumer identified health outcomes of priority. Stage 1 will involve recruitment of pregnant participants and their partners at 14 weeks gestation, with dense phenotype data and biological samples collected at 14, 20, 28 and 36 weeks gestation and serial ultrasound measures at 20, 28, 36 and 40 weeks, with postpartum follow-up at 6 weeks and 6 months. Biological samples will be used for biomarker discovery and sequencing of the genome, transcriptome, epigenome, microbiome and metabolome.
Ethics and dissemination Ethics approval was obtained from Hunter New England Local Health District Ethics Committee (2020/ETH02881). Outcomes will be published in peer-reviewed journals, disseminated to participants through the NEW1000 website, presented at scientific conferences, and written reports to local, state and national government bodies and key stakeholders in the healthcare system to inform policy and evidence-based practice.
- Family Cohort Study
- Pregnancy
- Child Development
- Developmental Origins of Health and Disease
- DOHaD
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Strengths and limitations of this study
Dense phenotype data collected at multiple timepoints relating to physical health, environmental exposures, health behaviours, socioeconomics, models of care, mental health and relationships.
Questionnaire data collected through use of validated tools, use of standardised and validated protocols for physical assessments.
Ability to capture complex family structures reflective of contemporary Australian society.
Three years of consultation with community and healthcare stakeholders (including two of Australia’s largest healthcare consumer representative organisations Red Nose and Miracle Babies), researchers, healthcare providers, Aboriginal stakeholders, including Elders, from metropolitan and regional areas and culturally and linguistically diverse families. Ongoing involvement of healthcare consumers through the NEW1000 Healthcare Consumer Committee.
High costs of maintaining the cohort. Ongoing assessment will be heavily dependent on philanthropic support, government funding or competitive grant success.
Introduction
Over 30 years of research in both human and animal models have demonstrated the relationship between adverse antenatal and postnatal environments and increased risk of child and adult diseases.1–6 These diseases include cardiovascular disease,7 hypertension,7 8 diabetes,7 obesity,9 fatty liver disease,5 stroke,10 asthma,11–13 allergies,14 neurodevelopmental disorders,15 mental health16 as well as cancer.17 18 Captured by the Developmental Origins of Health and Disease (DOHaD) concept, epidemiological, clinical and basic science studies have demonstrated this relationship extends from previous generations through the periconception period into childhood.6 The first 1000 days from conception is a critical period of growth and development. It is the window in life with the greatest risk of developmental programming; it is also the window with the greatest opportunity for prevention.19
The contribution of previous Australian birth cohorts to the field of DOHaD is extensively discussed elsewhere.20 21 While these cohorts have provided significant contributions to health research, there remains a need for newly established pregnancy cohorts in Australia, as the majority of these studies were established more than 20 years ago, 50% did not include antenatal measures and less than half involved partners.20 21 These cohorts often captured a very specific demographic within Australia and, although longitudinal in nature, are inherently susceptible to socioeconomic, social, environmental and cultural changes. For example, since the establishment of a number of the older cohorts, there has been a rapid shift towards calorically dense but nutritionally poor ‘fast food’, a decreased need for incidental exercise due to transport accessibility, and the exponential growth in use of technology for communication, work and leisure.
In addition to social, cultural and environmental changes over the past two decades, new technology and -omics (such as genomics, transcriptomics, proteomics, epigenomics, microbiomics, metabolomics and fragmentomics) have transformed how we understand the mechanisms underlying human health. Precision medicine, a multidimensional approach to healthcare incorporating environment, lifestyle and clinical information, describes the definition of disease at a higher resolution by genomic and other technologies to enable more precise targeting of subgroups of disease with new therapies.22 Studies in established human cohorts where -omics data exist have resulted in rapid advances in our understanding of the early origins of health and disease, through analyses of gene–environment interactions.23 Unfortunately, not all cohorts have repeated bio sampling over the first 1000 days of life from conception with samples collected and curated specifically for multi-omics analyses.24 The Newcastle 1000 (NEW1000) Study will provide detailed, longitudinal, multisystem phenotyping and serial sample collection for meta-omics analyses. Specifically, samples will be collected to assess the genome, epigenome, transcriptome, fragmentome, proteome, metabolome, microbiome and exposome.
The NEW1000 Study is the first population-based pregnancy cohort study in New South Wales (NSW) to be established in the last 10 years that will recruit women earlier than 18 weeks gestation, obtain repeated biological sampling and questionnaire data, directly involve partners, be situated in a regional area, and involve a team of multidisciplinary researchers to allow multiple health outcomes to be investigated.25–29 Collecting in-depth socioeconomic, demographic and health data, including mental health, dietary information, microbiome measures and biochemical indicators of stress will enable a complete picture of the complex gene–environment interactions that underpin multiple health and developmental outcomes.24 As one of the few pregnancy studies with complete family data sets, including questionnaire and biological samples from paternal participants, and the ability to capture complex family structures (including step-parent, same sex families and single parent families), the NEW1000 Study will provide a relevant and up-to-date database of families, reflective of current Australian society.
Methods
Study design
The NEW1000 Study is a prospective, longitudinal pregnancy cohort study which will involve three stages. Stage 1, the focus of this protocol paper, will centre on pregnancy health, fetal development and early infant development up until 6 months postpartum. Precision medicine approaches will be used to develop improved early screening tools and interventions for adverse pregnancy outcomes, which currently affect up to 25% of pregnancies. Stage 1 began in March 2021 and will involve recruitment and assessment of 500 families each year for 5 years, involving in-person assessments, biological sampling, ultrasounds and online surveys. Stage 2 will include in-person assessment, online surveys and biological sample collection from families when the child is 12, 24 and 36 months old. Stage 3 will involve the long-term follow-up of families through online surveys and data linkage.
Cohort selection and setting
The NEW1000 Study will be based in Newcastle, NSW which is the seventh largest city in Australia, situated in the Hunter New England Local Health District (HNELHD). While Newcastle is considered a regional centre, the population of Greater Newcastle is estimated to be 560 000 in 2023.30 Antenatal care in Newcastle can involve general practice shared care, midwifery care in community clinics, midwifery-led group practice, Aboriginal maternal and child health services care or private obstetric-led care. Recruitment for the study will be through the Initial Maternity Assessment and Planning (IMAP) clinic of the John Hunter Hospital (JHH), the largest tertiary healthcare facility in the HNELHD and the main obstetric hospital in the region, with ~4000 births annually. The JHH also provides a family-care team for women with additional support needs, drug and alcohol support services, social work services, a Mothers, Obstetrics, Multicultural Service for culturally and linguistically diverse women and a multidisciplinary clinic for high-risk pregnancies led by maternal–fetal medicine specialists. There are two other hospitals in the HNELHD which provide maternity services, one private (~1800 births annually) and one public (~1500 births annually), however, only the JHH provides universal comprehensive early pregnancy screening assessment (including first trimester ultrasound screening) between 11 and 13 weeks’ gestation, and comprehensive support programmes which assist women and families from culturally and socially diverse backgrounds. Recruitment of women from the JHH will thus allow enrolment in the NEW1000 Study to occur earlier than most existing pregnancy cohorts and provides a potential recruitment pool of women from diverse sociodemographic backgrounds.
Inclusion criteria
NEW1000 has broad inclusion criteria to ensure the cohort is representative of the population and includes any women over the age of 18 (unless parental consent is obtained), who attend the IMAP clinic between 11 and 13 weeks gestation and intend to reside in the area to facilitate long-term follow up. The IMAP service is used by 70% of the 3650 women planning to birth at the hospital (90% of births), with the remaining 10% of births consisting of late referrals.
Exclusion criteria
Exclusion criteria for NEW1000 include (1) high dependence on medical care including recent intensive care unit (ICU) admission or life-limiting comorbidity, (2) surrogate pregnancies where the biological mother will not be the child’s legal guardian, (3) cognitive impairment that prevents completion of data collection forms, informed consent or the ability to understand written or verbal instructions and (4) if one parent does not consent to the child being part of the study (however, single mothers will be eligible to enrol themselves).
Recruitment and consent
During attendance at the IMAP clinic, women will receive a flyer about the study via QR code in their digital hospital information packs to read and discuss with partners, family or friends. A follow-up text will then be sent the following day to all women (with the exception of those who have a fetal demise recorded), with an option to decline being contacted by a member of the research team for additional information about the study. A research midwife or nurse will then contact potential participants via follow-up phone call to explain the study in more detail. If the woman decides to join the study, they will be verbally consented over the phone and sent an email with the participant information and consent forms. Written informed consent will be undertaken during the initial study appointment at the Hunter Medical Research Institute (HMRI) at 14 weeks gestation. As the study will be recruiting for a period of 5 years, it will be likely women will be enrolled with consecutive pregnancies. To account for consecutive enrolment and ensure correct and up-to-date records concerning changes in partners or living arrangements, there will be three separate databases; one for the mother, one for the partner or biological father and one for the pregnancy and child. Information from the parental databases will be linked to each pregnancy record, allowing parents to have one individual record which can be linked to multiple pregnancy records. Changes in parent records will be piped into the linked pregnancy record to reduce administration and participant burden and likelihood of data entry error. Consecutively enrolled participants will be consented for each pregnancy.
Stage 1 data collection timepoints
Stage 1 assessments will be scheduled at 14, 20, 28, 36 and 40 weeks gestation, birth, 6 weeks and 6 months postpartum (online supplemental table 1).
Supplemental material
Biological samples
With the exception of samples collected at-home, including faecal swabs, toenail samples and early morning saliva samples for cortisol analyses, all biological samples will be collected by clinical research midwives or nurses when participants attend their study appointment at the clinical research facility of HMRI. Pregnant participants will be given a pack containing collection containers and swabs, with written instructions, for at-home samples during their 14-week and 28-week appointments. These will be returned at their next appointment. At-home samples will be requested from partners attending HMRI during the 20-week appointment and returned by the pregnant participant at their next appointment at 28 weeks.
Maternal venous blood will be collected in ethylenediaminetetraacetic acid (EDTA), PAX RNA, lithium heparin and serum tubes to allow thorough analyses and ample quantitates of DNA, cell-free DNA and RNA for both immediate and future studies. Collection of blood will also allow assessment of glucose, cortisol, lipids, iron, insulin, biochemistry and other potential biomarkers. To facilitate accurate measurement of stable endogenous insulin levels, lipid profiles and other analytes, maternal samples will be collected after fasting overnight at two timepoints, 14 and 28 weeks gestation. Maternal blood samples collected at 20, 36 and 40 weeks gestation will be non-fasting. Partner blood samples will be taken once during pregnancy at the 20-week appointment and will not include PAX RNA. Cord blood will be obtained at birth and a neonatal blood spot obtained by collecting an additional newborn screening card during routine newborn screening. Blood samples will be processed and divided into aliquots to preserve independent volumes for multiple ongoing and future studies. PAX RNA tubes will be kept upright at ambient temperature for a minimum of 2 hours, then frozen upright at −20ºC for 24 hours, before finally being transferred to −80ºC to prevent cracking of the tubes and subsequent loss of sample, as per recommended guidelines.31
Maternal urine samples will be self-collected for analyses of renal function and dietary markers at all timepoints during pregnancy and 6 weeks postpartum while the participant is attending their appointment at HMRI. Partner urine samples will be self-collected during the 20-week appointment. Infant urine samples will be collected by research midwives or nurses, using gauze inserts, on the postnatal ward and at postpartum appointments, scheduled at 6 weeks and 6 months. Maternal and partner early morning saliva samples will be self-collected for baseline cortisol the morning of the 20-week appointment, with an additional maternal sample collected at 36 weeks to measure change in baseline cortisol throughout pregnancy. Maternal swabs for analyses of the microbiome will be collected from skin, mouth, vagina and stool at various timepoints antenatally and postnatally, with partner swabs collected for skin, mouth and stool at 20 weeks gestation. Maternal, partner and infant buccal swabs will also be collected for epigenetic analyses.
Maternal and partner hair samples will be collected at 20 weeks gestation for historical cortisol analyses, with an additional hair sample collected from the mother and infant at 6 weeks postpartum. Maternal and partner toenail samples will be collected at 20 weeks gestation for toxicology, with an additional sample from mothers and infants at 6 weeks postpartum.
Samples collected on the day of birth will include maternal (chest) skin and vaginal swabs (self-collected pre-birth), cord blood and placenta. A small colostrum sample will be requested once the mother is on the postnatal ward. Breastmilk samples will be collected at 6 weeks and 6 months postpartum if the mother is breast feeding.
All blood, urine, saliva, swabs, colostrum, placenta and breastmilk samples will be de-identified and stored in the NEW1000 Study Biobank facility at −80ºC. Toenail and hair, deemed ‘dry samples’ are collected for study of environmental exposures, toxicology and cortisol and will be stored in a dry, temperature-controlled biobank. All samples are processed within the Mothers and Babies Research Programme at HMRI and subject to appropriate PC2 laboratory practices prior to storage.
Ultrasound
Consent for the study includes access to all ultrasound assessment data from clinical ultrasounds performed at JHH. Study ultrasounds at 20, 28 and 36 weeks are planned 8 weeks apart in order to appropriately assess fetal growth and develop tools to improve the detection of fetal growth disorders (eg, fetal growth restriction and macrosomia). Data from 40-week ultrasounds will be used to develop tools to evaluate post-dates pregnancy safety. Ultrasounds will be performed on a GE Healthcare Voluson E10 BT21 Ultrasound unit using ViewPoint6 data management software. All measurements will be taken in triplicate on an ultrasound machine where the reference ranges have been removed to reduce operator bias during assessments.
At 20 weeks gestation, a detailed fetal morphology scan will be performed including fetal number, fetal cardiac activity, fetal biometry, a detailed fetal anatomic survey, subjective evaluation of amniotic fluid volume and placental position and Doppler ultrasound studies of the maternal uterine arteries, the fetal umbilical arteries, middle cerebral artery and ductus venosus. At 20 weeks and 28 weeks gestation, cervical length and cervical elastography will be measured by transvaginal ultrasound. Abdominal subcutaneous fat will also be measured at each scan. At 28, 36 and 40 weeks gestation, fetal growth and well-being will be reviewed through the assessment of fetal cardiac activity, fetal biometry, Doppler studies, placental location and amniotic fluid volume. Infant ultrasound to assess aortic intima media thickness will be performed at 6 weeks of age (adjusted for preterm infants) to investigate the long-term impact of early life cardiovascular phenotype.32 All assessments will be performed by an experienced and registered team of sonographers and formally reported on by a Maternal Fetal Medicine Specialist. Results will be added to participants hospital medical records. Long-term storage of study-related ultrasound data will involve merging of ViewPoint data into the secure NEW1000 Study REDCap database.
Physical assessments
At each timepoint maternal weight and body composition will be measured in a CosMed BodPod Unit using non-invasive air displacement plethysmography.33 Data generated from these measures will be used to develop normative ranges of body composition in pregnancy. Partner body composition will be measured at the 20-week gestation appointment. Assessments of blood pressure and resting heart rate will be measured using Welch Allyn digital BP units at each assessment for mothers and at the 20-week timepoint for partners. During the first appointment baseline measures of maternal fitness including hand grip strength, measured using a Takei hand grip dynamometer, and a 30 s sit-to-stand test will be performed. Actigraph wrist accelerometers will be fitted on mothers at 14 weeks gestation for 1 week to obtain early pregnancy physical activity data and re-fitted at 20, 28 and 36 weeks to measure changes in physical activity. Activity logbooks will be used to record static, resistance or cycling activities which may not be captured by the accelerometers. Accelerometers and logbooks will be returned in postage paid envelopes after 7 days.
Infant assessments and measurements including abdominal and head circumference, middle upper arm circumference, length, weight and body composition (measured by the CosMed Peapod unit)34 will be undertaken on the postnatal ward of the hospital and at HMRI during the 6-week and 6-month postpartum appointments. A subgroup of infants will receive infant lung function testing at 6 weeks postpartum, using previously published protocols.35–37
Questionnaires
A link to online questionnaires will be emailed to participants at 14, 20, 28 and 36 weeks antenatally and 6 weeks and 6 months postnatally. Questionnaires will be ‘open’ for 2 weeks at each timepoint and participants will be able to save and return to the questionnaires if they cannot complete them in one sitting. Demographic information including education, socioeconomic status, employment and income, housing, relationship status, ethnicity, cultural identity and languages spoken will be obtained. A comprehensive health history including reproductive health will be included in the initial survey, with changes in relevant information updated in subsequent surveys. Validated questionnaires will be used throughout the study to collect information on important health domains including physical activity,38 sleep quality,39 respiratory health,40 41 allergies,42 health-related quality of life,43 diet,44 social support,45 mental health,46–48 gut health49 and child development.50 Smoking, vaping, nicotine replacement therapy, drug, alcohol51 and medication use will also be recorded at each timepoint. A COVID-19-related questionnaire including vaccination status, financial and psychosocial impacts will be included to record potential effects of the pandemic on maternal health and well-being and any subsequent child health and development outcomes.
Clinical record access
During Stage 1, consent to access clinical medical records (including eMaternity, ViewPoint and Clinical Applications Portal) will be obtained from participants to enable inclusion of important clinical data and to reduce participant burden. Long-term planning includes data linkage to national databases such as the Births, Deaths and Marriages registry, and the National Assessment Programme—Literacy and Numeracy, which will take place during Stage 3 of the study.
Statistical analysis
The Newcastle 1000 Study is designed to investigate outcomes spanning from the time of conception to adulthood. Considerations were included to ensure sufficiently large sample size to allow the investigation of incidences of diseases and distribution of phenotypic measures within the population, and differences in implemented interventions. Further, a conservative rate of 10% was used to account for lost to follow-up from the time of recruitment to the 6th month infant follow-up (Stage 1). Previous cohort studies in Australia have recorded low deaths, lost to follow-up or withdrawal rates of 3.4% from enrolment to birth, and 5% from enrolment to 12 months.52 Where possible, all data captured will be recorded as continuous measures to allow the extraction of maximum information content. Preliminary data analyses will include comparison of key demographic and characteristics of the cohort to the broader population to assess cohort representativeness, in line with previous pregnancy cohorts.28 52 Parental characteristics including age, socioeconomic status, education and ethnicity and pregnancy-related variables such as parity, pregnancy-related complications, gestation at birth, neonatal intensive care admission, birth weight and caesarean section rate will be included in the analyses.
Initial planned analyses for Stage 1 will include outcomes relating to pregnancy and obstetrics, maternal mental health and infant respiratory function. Specific pregnancy and obstetric outcomes would include gestational diabetes, pre-eclampsia, gestational age at birth, birth weight and neonatal intensive care admission. The impact of healthy nutrition in infancy on outcomes at the 6th month follow-up will also be examined.
A total of 2500 study participants will ensure a sufficiently powered study to estimate the prevalence of uncommon (~5%) and common (>45%) disease, accounting for an absolute error of 1% and 3%, respectively.53 For continuous traits, it is estimated that a minimum sample size of 1844 participants is needed to detect deviations from the population after accounting for non-normality in the trait.54 Assuming a two-category group for nutritional status and stratifying the study population into five quintile groups, a minimum of 2154 participants would allow the detection of small to medium effects of an intervention.53 For individual projects proposing to use the cohort study data, a description of the statistical analyses, including power calculations specific to each project, will form part of the application to the NEW1000 Study Executive.
Statistical analyses will be performed using standardised software. Missing outcome data will not be imputed, as missing data are not likely to follow key assumption of data missing at random within this population. However, we will conduct sensitivity analyses using multiple imputation methods to explore potential impact of missing values. Baseline characteristics of participants will be summarised using descriptive statistics and associations will be described using uni- and multivariate analyses. The level of significance is defined as a p value of less than 0.05, correcting for multiple testing where indicated. Continuous variables will be reported as numbers of observed and missing values, and as mean and SD, or median and range as appropriate. Categorical variables will be reported as frequencies and percentages.
Ethics, governance and regulations
Ethics and dissemination
The NEW1000 Study was approved by the Hunter New England Human Ethics Committee (2020/ETH/02881) on 8 December 2020. All proposed projects using NEW1000 data and/or biological samples will be required to have ethics and safety clearance. Funding for Stage 1 of the NEW1000 Study has been provided through HMRI Philanthropy and The University of Newcastle Research Stimulus Funding. Findings from the study will be published in peer review journals, presented at medical conferences and formally reported to appropriate governing bodies at local, state and federal level to inform policy and processes relating to pregnancy healthcare and child development. Presentation of findings will be disseminated locally via online and in-person research seminars as required by the funding bodies, hospitals and collaborating institutes. Aggregate findings will be made available annually to all research participants via the NEW1000 website participant newsletter.
Quality control and participant safety
All NEW1000 Study staff will be centrally trained and required to demonstrate sufficient ability in data collection, biological sample collection and informed consent processes prior to performing each procedure. Staff will be trained in anthropometric assessments (including body composition using the Bodpod), venous puncture, microbiome swab collection, physical fitness testing and data entry. Any incidental findings which may be clinically relevant will be reviewed by clinical staff and, if necessary, referred to a maternal–fetal medicine specialist. All ultrasound data will be formally reported and printed in triplicate with one copy returned to the hospital medical records, one sent to the participant and one to their treating physician.
Data will be collected in REDCap (Research Electronic Data Capture), a secure web-based purpose-built software application for the conduct and management of medical research surveys and case report forms for clinical trials. Annual audits on 10% of data will be scheduled to check means, SD and outliers to maintain a high-quality control and identify issues in collection efficiently to reduce skewing or obtaining unusable data. To ensure the cohort is representative of the population, the first 500 participants will be compared with de-identified hospital record data for key demographic and socioeconomic variables. If recruitment is found to result in under-representation of a particular group, targeted recruitment strategies will be developed in conjunction with the NEW1000 Study Healthcare Consumer Committee and key stakeholders.
Study governance
Governance of the data and biological samples will be controlled by the NEW1000 Study Executive Committee who will meet quarterly to review the studies strategic plan and assess applications for data and sample analyses. All samples and associated data will remain under the governance of the NEW1000 Study Executive Committee and access will be subject to a formal application process and approval obtained through the committee. Approval will only be permitted for projects that are registered and certified by a Human Research Ethics Committee. All samples and data shared with researchers will be in de-identified form. The NEW1000 Study is composed of 20 research areas, each led by a senior researcher who is responsible for the development of studies, research projects and hypotheses for their area of expertise. All substudies based on research questions generated by research theme leaders will require applications to the Study Executive and, if there is substantial additional data or assessments required for their implementation, a separate Ethics application. Data-based studies using existing data will require Study Executive approval, with all analyses and manuscripts to be approved prior to publication to avoid replication and promote collaboration. The NEW1000 Study Healthcare Consumer Committee form part of the governance structure and will meet bi-annually with the Study Director and Study Coordinator.
Patient and public involvement
Development of the NEW1000 Study began in March 2018 with a meeting of community members and key stakeholders from the University of Newcastle, HMRI and HNELHD. This was followed by seven healthcare consumer workshops involving first time parents, women who experienced pregnancy or child loss, women who experienced preterm birth, Aboriginal women from Newcastle and women and Elders from the Gomeroi gaaynggal study,55 culturally and linguistically diverse women, and fathers. Each focus group was asked open-ended questions about pregnancy health and population health issues of importance for research, preferred recruitment approaches, information presentation and communication methods. Following focus groups, online surveys were completed by participants to rank the identified health issues by importance. Participants ranked stillbirth, preterm birth, high blood pressure and preeclampsia, maternal mental health, breast feeding and early nutrition, and birth-related issues as highly important. In addition, population health issues including hypertension and cardiovascular disease, mental health and well-being, allergies and immune dysfunction, obesity and diabetes were identified as priority areas for research. Engagement and focus group feedback informed all aspects of the cohort design, from recruitment through to presentation and dissemination of outcomes. Ongoing consumer engagement is structured into the governance of the study through the NEW1000 Study Healthcare Consumer Committee. Retention strategies for Stage 1 will involve maintaining the NEW1000 website with up-to-date information for enrolled families, including lay-language publications of study findings, developed with the Healthcare Consumer Committee and regular use of social media platforms.
Ethics statements
Patient consent for publication
Acknowledgments
We acknowledge the Awabakal and Worimi people as the traditional custodians of the land on which the NEW1000 Study is conducted. We pay respects to the Elders of this community past, present and emerging. NEW1000 acknowledges the families who have participated in the study and recognise the invaluable contribution they have made to this research. We acknowledge and thank the staff of the John Hunter Hospital for their ongoing support and contributions to the project, the birth suite midwives for the collection of birth samples, and the NEW1000 staff for their dedication to the study. We thank staff at Microba for their collaboration and support.
References
Supplementary materials
Supplementary Data
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Footnotes
Twitter @SarahValko
Collaborators The following are members of the NEW1000 Study Research Collaboration and have been integral to the design of the study; Craig Pennell (UON-HMRI), Roger Smith (UON-HMRI), Mike Calford (HMRI), Clare Collins (UON-HMRI), Frances Kay-Lambkin (UON-HMRI), Rodney Scott (UON-HMRI), John Attia (UON-HMRI), Vanessa McDonald (UON-HMRI), Vanessa Murphy (UON-HMRI), Penny Reeves (UON-HMRI), Joerg Mattes (UON-HMRI), Craig Gedye (UON-HMRI), Tracey Dudding-Bythe (UON-HMRI), John Wiggers (UON-HMRI), Nick Talley (UON-HMRI), Simon Keely (UON-HMRI), Maralyn Foureur (UON-HMRI), Kirsty Pringle (UON-HMRI), Peter Gibson (UON-HMRI), Emily Hoedt (UON-HMRI), Andrew Boyle (UON-HMRI), Andrew Searles (UON-HMRI), Jay Horvat (UON-HMRI), Mitch Duncan (UON-HMRI), Sarah Valkenborghs (UON-HMRI), Linda Campbell (UON-HMRI), and Emily Freeman (UON-HMRI).
Contributors TG, JF and CEP wrote the manuscript. TG and CEP designed the NEW1000 Protocol. JM and VEM contributed to the protocol design for respiratory health and infant lung function. RS, JJH and SRV participated in NEW1000 protocol development and reviewed the final manuscript. CW wrote the statistical analysis and power calculation section and reviewed the final manuscript. All members of the NEW1000 Executive and the NEW1000 Study Research Theme Leaders contributed to the aims and design of the study.
Funding Stage 1 of The NEW1000 Study is made possible by financial support from anonymous donors through HMRI Philanthropy and the University of Newcastle Research Stimulus Funding.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Ethics, governance and regulations section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.