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Research | PERSIANLineageCohort Home Site Mape Contact Us   PERSIANLineageCohort Previous Pause NextWell-nighThe StudyBackground Vision Goal ObjectiveWell-nighUsOrganization Project Management International partnerships ResearchProtocol Conceptual framework Study setting Data hodgepodge Health determinants & outcomes Data hodgepodge methods Data hodgepodge in Phase 1 Data hodgepodge in Phase 2 Quality tenancyUpstandingconsiderations Study Questionnaires NewsNews Steering Committee Meetings The PBC Gallery Related LinksPERSIANLineageCohort PERSIAN Cohort InternationalLineageCohorts Contact Us Research Protocol Conceptual framework Study setting Data hodgepodge Health determinants and outcomes Data hodgepodge methods Data hodgepodge in Phase 1 Data hodgepodge in Phase 2 Quality tenancyUpstandingconsiderations Study questionnaires Protocol: In this cohort study, the data hodgepodge will be based on six methods (physical examinations, questionnaires, tests, clinical data, biological samples, and survey of living environment) that complement each other in order to imbricate multiple aspects of determinants of health and health outcomes. We will use standardised questionnaires and protocol unromantic by lineage cohorts in Europe, which will facilitate publication of results of our analyses in leading international journals and moreover will ultimately make it possible for pooling data and conducting joint-analyses with European cohorts in future. Because of the financing and practical reasons, it will not feasible to collect all the desired data (as listed below) for all planned mother-child pairs for the cohort. We will therefore use a novel 3-level nested design: A.Unstipulatedcohort: a survey of 150,000 pregnant women wideness all designed centres for which we will collect data on: Physical viewing Questionnaires Tests Clinical data Biological samples Living environment B.Wholesalesub-cohort: 10,000-15,000 pregnant women selected from the unstipulated cohort in large centres for which in wing to the data that we collect for the unstipulated cohort, we will collect data on Tests Biological samples C. Omics sub-cohort: 5000-7000 pregnant women selected from the wholesale sub-cohort for which in wing to the data that we collect for the unstipulated cohort and wholesale sub-cohort, we will collect data on Tests Biological samples: Living environment Conceptual framework: We will collect data on both “determinants of health” and “health outcomes”. Our evaluation of the “determinants of health” will encompass all three domains specified by WHO: socioeconomic environment, physical environment, and individual characteristics and behaviours (Figure 1). As described below, for each domain we will collect data on a number of sub-domains which, based on misogynist literature, can be relevant to pregnancy outcomes, child mental and physical development, and early- and late-onset chronic non-communicable diseases. Figure 1. Health determinants and outcomes covered by the project. Study setting: The PERSIAN lineage cohort will be established in a number of centres for the PERSIAN sultana lineage cohort and will make use of once misogynist infrastructures for these cohorts. The pilot phase will be conducted in Isfahan and Yazd. A unravelment of vital characteristics of these centres is presented inthe table below: Recruitment of participants We will select a combination of public and private healthcare providers in order to ensure they represent the ethnic and socioeconomic distribution in the underlying population. Pregnant women will be approached during their first pregnancy visit (at the end of first trimester) to these centres. Those consenting will be recruited if they have Iranian nationality, reside in the catchment zone of the study centre, have a singleton pregnancy, requite lineage in the reference hospital, have not used assisted reproductive techniques, and do not have any liaison problem. The upper rate of Caesarean section in Iran will provide PERSIAN lineage cohort a unique opportunity to evaluate the short- and long-term health effects of Caesarean section. The child’s biological father will be moreover invited to participate in the study at the first pregnancy visit (directly if peekaboo the visit and indirectly through reports if they are not peekaboo the visit). Data collection: Data hodgepodge will involve mother, father, and the child in the pursuit five subsequent phases: Phase 1: Periconception till lineage Phase 2: Infancy (0-2 years) Phase 3: Childhood (3-11 years) Phase 4: Adolescence (12-18 years) Phase 5: Adulthood (19-30 years) A unravelment of data hodgepodge timeframe is presented in Table 1. Table 1. The phases and time points of data collection. Health determinants and outcomes: Data on a wide range of determinants of health and outcomes will be placid as detailed in Table 2. Table 2.Unravelmentof planned placid data. 1 Smoking, swig consumption, recreational drug use 2 Including syphilis, toxoplasmosis, rubella, cytomegalovirus infection, herpes simplex, hepatitis B & C, HIV, urinary track infections, vaginal GBS colonisation, and chorioamnionitis. 3 Including placenta praevia and placenta abruption 4 City and healthcare centre (or home) 5 Normal vaginal delivery, assisted vaginal wordage (induction, forceps, vacuum, amniotomy, and/or episiotomy), and caesarean section (elective, emergent, or during labour) 6 Stillbirth, maternal mortality, prolonged labour, haemorrhage, uterine atony, foetal distress, umbilical string prolapse/compression, nuchal Cord, and meconium aspiration. 7 Analgesics/anaesthetics, antibiotics, beta2-simulators 8 Including length of gestation (days) and premature rupture of membranes 9Lineageweight, length, throne circumference, and indications of IUGR. 10 Height, weight, skinfold, waist circumference, hip circumference, and bioelectrical impedance wringer 11 Lung function test (TLC, FEV1, FVC, FEV1/FVC) 12Thoroughbredpressure and cardiac output 13 Iron-deficiency anaemia and G6PD deficiency   Data hodgepodge methods: Our vision is to secure the potentials for international collaborations and taking part in consortia of European and regional cohorts in future international research projects. Accordingly, we will wield standardised questionnaires and protocols that are tailored and, where available, validated for the Iranian population and at the same time unromantic by established lineage cohorts in Europe (e.g. INMA, MOBA, BiB, Generation R, and ALSPAC). This tideway can moreover facilitate publication of the findings of PERSIAN cohort in upper impact international journals. The data hodgepodge will be based on the pursuit methods that complement each other in order to imbricate multiple aspects of determinants of health and health outcomes: Computerized questionnaires Biological samples Physical examinations Clinical tests Hospital records Survey of living environment Measures to ensure upper turnout during follow-ups At the time of recruitment, we will obtain the pursuit information in order to unzip multiple was to wangle the percipients: XXX To unify the follow-up visit, first we will send a letter to participants one month surpassing their follow-up time, informing them well-nigh the upcoming follow-up and what that follow-up will include (e.g. topics of questionnaires, types of biological samples, clinical exams, etc). Two weeks prior to the visit, the participants will be contacted over the phone and will be asked well-nigh their time availability to personize the time and the stage for the visit. One week and one day surpassing the visit, the participants will be sent reminder text messages. Data hodgepodge in Phase 1: Phase 1 Data hodgepodge diamond Because of the financing and practical reasons, it will not feasible to collect all the desired data (as listed below) for all planned mother-child pairs in the cohort. Therefore, spare detailed data hodgepodge will be conducted in a selected subgroup of children and their parents from foetal life onwards. A.Unstipulatedcohort: a survey of 20,000 pregnant women wideness all designed centres for which we will collect data on: Physical viewing (as described below) Questionnaires (as described below) Clinical tests (mother): Fasting thoroughbred sugar Ultrasound viewing (Twice at first and third trimesters to assess foetal growth and gestational age) Clinical data (as described below) Biological samples MotherThoroughbred(once) Urine (once) Hair (once) Nail (once) Skin swab (once) Faeces (once) Father Saliva (once) Newborn Hair (once) Dried thoroughbred spot (once) Meconium Living environment Geocoded home addresses Home characteristics (as described below) B. Omics sub-cohort: 5000-7000 pregnant women selected from the unstipulated cohort for which in wing to the data mentioned whilom for the unstipulated cohort, we will collect data on Clinical tests (mother) Ultrasound viewing (once each trimester to wangle foetal growth (the second trimester viewing should occur virtually week 20), smart-ass minutiae and psychosomatic ventricular volumes, fetal umbilical street and the middle and proemial psychosomatic arteries, and placental echogenicity and perfusion) Neuropsychological tests (once) Biological samples: MotherThoroughbred(once per trimester and once at delivery) Urine (once per trimester) Faeces (once per trimester) Skin swab (once) Colostrum Saliva (once per trimester) Vaginal swab (once at the third trimester) NewbornStringblood Placenta Umbilical string Father Skin swab Living environment Home indoor environment sampling (as described below) Home surrounding environment (as described below) Settled pebbles (Twice at 1st and 3rd trimesters) Phase 1 data hodgepodge methods We will collect data from the mother, father, and the child using questionnaires, biological samples, physical examinations, clinical tests, hospital records, and survey of the living environment as detailed in table 3. The tasks planned for each Phase 1 visit are detailed in Table 4. Table 5 describes the information planned to be placid through questionnaires. Table 6 details methods that will be unromantic to assess exposure to environmental factors. Data hodgepodge for the mothers and children using questionnaires, biological samples, physical examinations, and clinical tests will be conducted in the PERSIAN cohort centres. In each PERSIAN cohort centre, a team consisting of a unstipulated practitioner, a nurse, and a psychologist will self-mastery face-to-face interviews with participants to fill the questionnaires (psychologist), physical examinations (GP), and obtain and process biological samples (nurse). Participants in phase 1 are pregnant women and their husbands. In phase 2, participants will be mother-child pairs and the father of the child who were enrolled in phase 1. At their visits to the PERSIAN cohort centres, the mothers will be asked to take self-administered questionnaires for the fathers and return the filled questionnaires in their next visit. The answers will be checked by PERSIAN cohort stuff and if the answers to some questions were missing, the participants will be tabbed on the phone and will be asked to wordplay those questions (for details on the follow-up protocol see section...). We will assign two full-time midwives to each participating hospital in order to obtain data from hospital records of the participants and collect biological samples at the time of birth. The home visits (for geocoding and characterizing the home environment) will be carried out by an environmental health technician. To enhance the compliance among the participants, it is prudent to recruit sexuality staffs for all the same positions. Table 3. Data hodgepodge methods and timeline during Phase 1. Table 4. Tasks during each Phase 1 visits. Tasks with underlined fonts wield to both father and mother, those in unvigilant fonts wield to child, and those in normal fonts only wield to mothers. 1 To determine gestational age, to monitor foetal growth, to determine mental development, and to evaluate placental echogenecity and perfusion 2 working memory, IQ, verbal skills Table 5.Unravelmentof questionnaires used in Phase 1. Table 6. Assessment of exposure to environmental factors.   Data hodgepodge in Phase 2: Phase 2 Data hodgepodge diamond In Phase 2, we will follow pilot study participants and Phase 1 unstipulated and omics cohorts: A.Unstipulatedcohort: for which we will collect data on: Physical viewing (child) Anthropometric measures Height, weight, and throne circumference: every two months from log-book Skinfold thickness (triceps and sub-scapular), mid-upper arm circumference, waist circumference, and hip circumference: three times at 6, 12, and 24 months Motor minutiae (WHO milestone questionnaire)Thoroughbredpressure (twice at 12 and 24 months) Auditory test (once at 6 month) Questionnaires (child) Child Infections (three times at 6, 12, and 24 months) Time-activity (twice at 12 and 24 months) Asthma and wheeze (6, 12, and 24 months) Allergy, eczema, and supplies allergy (6, 12, and 24 months) Diet (breastfeeding, multivitamin/supplements, etc.) (three times at 6, 12, and 24 months) Medication (three times at 6, 12, and 24 months) Hospital admissions (three times at 6, 12, and 24 months) Passive smoking (three times at 6, 12, and 24 months) Neonatal jaundice (Once at 6 months) Mother Mental health (depression, anxiety, life events) Occupation/employment (mother and father) (Once at 12 months) Home move (three times at 6, 12, and 24 months) Home characteristics: presence of pets and animals (twice at 6 and 24 months) Antibiotic use (three times at 6, 12, and 24 months) Noise (Twice at 6 and 24 months) Change in marital status (three times at 6, 12, and 24 months) Health superintendency and clinical data (child) Vaccination history: every two months from the log-book Growth curve: every two months from the log-book Biological samples Child Urine (twice at 6 and 24 months) Dried thoroughbred spot B. Omics sub-cohort: Physical viewing (child) Anthropometric measures: Skinfold thickness (triceps and sub-scapular), mid-upper arm circumference, waist circumference, and hip circumference (an uneaten time at 2 months) Eye refraction (twice at 12 and 24 months) Anogenital loftiness (Once at 2 months) Questionnaires Child FFQ (three time at 6, 12, and 24 months) Pacifier use/thumb sucking (6, 12, and 24 months) Household pesticide use (6 and 24 months) BPA/Phthalates Sleep disturbance (6, 12, and 24 months) RF/ELF exposure (twice at 6 and 24 months) Mother Child and mother relationship (once at 6 months) Social support (once at 6 months) RF/ELF exposure(twice at 6 and 24 months) Sleep disturbance (three times at 6 and 24 months) Contraceptive use (twice at 12 and 24 months) Menstruation (twice at 12 and 24 months) Father Mental health (depression, anxiety, life events) Sleep Clinical tests Structural MRI and resting state fMRI and Diffusion tensor imaging (DTI) MRI for a subset of 100 children Biological samples ChildThoroughbred(once at 12 months) Urine (four times at 2, 6, 12, and 24 months) Faeces (four times at 2, 6, 12, and 24 months) Hair (four times at 2, 6, 12, and 24 months) Nail (three times at 6, 12, and 24 months) Skin swab (12 months) Saliva (12 months) Mother Faeces (12 months) Skin swab (12 months) Saliva (6 and 12 months) Breast milk (two times at 2 and 6 months) Living environment Settled pebbles (Twice at 2 and 24 months) Phase 2 data hodgepodge methods We will collect data from the mother, father, and the child using questionnaires, biological samples, physical examinations, clinical tests, hospital records, and survey of the living environment as detailed in table 7. The tasks planned for each Phase 2 visit are detailed in Table 8. Table 9 describes the information planned to be placid through questionnaires. Table 7. Data hodgepodge methods and timeline during Phase 2. Table 8. Tasks during each Phase 2 visits. Tasks with underlined fonts wield to both father and mother, those in unvigilant fonts wield to child, and those in normal fonts only wield to mothers. (Tasks in unvigilant fonts are carried out only for Omics Cohort) Quality control: Critical to the success of the study is upper quality data. Quality tenancy procedures will happen in three stages of the study: during preparation for data collection, during the process of data collection, and without data hodgepodge is finished.Surpassingstarting data collection, study staff will have training sessions. During data collection, reports of summary statistics regarding questionnaire and visit data hodgepodge items are necessary to ensure form completion, towardly use of skip logics and valid ranges. During and without the completion of data collection, data are quality controlled in real-time through the use of range limits and prompts for missing. Timetable Pilot study and Phases 1-2Upstandingconsiderations: Participation in the surveys is voluntary and participants have the right to withdraw from study at any time. Potential participants will be provided information well-nigh the study, measurements to be conducted and possible risks they may pose in written and oral formats. Those who decide to participate, will sign the informed consent form surpassing examinations start. Depending on the requirements of nationalValuesCommittee, the informed consent may include separate points for questionnaires, physical measurements, biological sample collection, and DNA testing, or may provide unstipulated consent for all included measures. All PERSIAN Cohort activities will be carried out equal to existing guidance in values as indicated in the Universal Declaration on Bioethics and Human Rights unexplored by UNESCO (19/10/2005). This project concerns the hodgepodge of personal information from the participants and biological samples including blood, urine, hair, nail, faeces, skin flora, deciduous teeth, milk, meconium, saliva, string blood, and placenta. PERSIAN lineage cohort will ensure standardized protocols are used and will collect biological samples. The hodgepodge of the biological samples is justified by the contribution of the research to be conducted on them to the improved understanding of an emerging risk of major public health interest, i.e., the role of early-life exposures in functional health in later life. The value of biological samples to be placid is such as not to constitute any significant undersong on the donors.Valuesapproval will be sought from the local values committees prior to starting the fieldworks. The pursuit procedures will be included in the research protocol to safeguard the privacy of study subjects: Reported study results will pertain to analyses of volume data. No individual’s name will be associated with any published or unpublished report of this study; Where personal information is used, including questionnaires and biological material it will be safety stored in secure facilities, and names will be replaced by unique study numbers, and stored separately. Primary databases and wringer files will be stored on computers with personal identifiers removed; Participants will be identified by a unique study number prescribed by staff of the partner organizations. This unique identifier will link all vital data required for the study. The master key file linking the centre’s study numbers with personal identifiers will be maintained in each centre; All files containing personally identifiable information, including the master key file, will be stored in password protected computer files.Wangleto these files will be limited to authorized project personnel; Hard reprinting records or computer generated records containing personally identifiable information will be stored in locked cabinets in an office with limited access; All project personnel will be trained in the importance of confidentiality of individual records and required to sign a confidentiality agreement. During the project life-span information will be accessed and handled by members of the research teams only, unless specific permission has been given by the upstanding committee. Study questionnaires: We will use standardised questionnaires and protocol unromantic by lineage cohorts in Europe (INMA, ALSPAC, GERONIMO/REMBRANDT/MobiKids), which will ultimately make it possible for pooling data and conducting joint-analyses with European cohorts in future.                 Quick LinkWell-nighThe StudyWell-nighUs Research News FAQ Related Links Contact Us Contact: Email: info@persian-bc.family © Copyright 2016-2018 by PERSIANLineageCohort. All Rights Reserved.DiamondBy NiCOMP.ir