protocolSection identificationModule nctId: NCT06297005, orgStudyIdInfo id: 21/FFP-P/10154, briefTitle: The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study, acronym: ECHO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University College Dublin, class: OTHER, collaborators name: Royal College of Surgeons, Ireland, descriptionModule briefSummary: Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age., conditionsModule conditions: Vaping, conditions: Pregnancy Related, conditions: Pediatric Respiratory Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Incidence of preterm birth, primaryOutcomes measure: Incidence of low birth weight, primaryOutcomes measure: Incidence of wheeze during the first two years of life, secondaryOutcomes measure: Incidence of smoking and vaping, secondaryOutcomes measure: Estimated foetal weight, secondaryOutcomes measure: Trends in carbon monoxide levels, secondaryOutcomes measure: Blood pressure measurements (both diastolic and systolic), secondaryOutcomes measure: Urine cotinine measurements, secondaryOutcomes measure: Incidence of maternal cough, wheeze and/or asthma, secondaryOutcomes measure: Maternal history of abnormal cervical screening cytology, secondaryOutcomes measure: Incidence of pre-eclampsia and/or hypertension during pregnancy, secondaryOutcomes measure: Incidence of birth complications, secondaryOutcomes measure: Edinburgh postnatal depression score, secondaryOutcomes measure: APGAR scores at 1, 5 and 10 minutes after birth, secondaryOutcomes measure: Admission to neonatal intensive care, secondaryOutcomes measure: Incidence of neonatal complications, secondaryOutcomes measure: Neonatal and paediatric anthropometric measurements over first two years of life, secondaryOutcomes measure: Neonatal body composition measurements, secondaryOutcomes measure: Incidence of respiratory illnesses, secondaryOutcomes measure: Number of attendances/admissions to hospital, secondaryOutcomes measure: Frequency of prescribed respiratory medications use, secondaryOutcomes measure: Barkely Functional Impairment score (BFIS), secondaryOutcomes measure: Early Executive Functions Questionnaire (EEFQ), secondaryOutcomes measure: Infant Behaviour Questionnaire (IBQ), secondaryOutcomes measure: Child Behaviour Checklist (CBCL), secondaryOutcomes measure: Early Childhood Behaviour Questionnaire (ECBQ), secondaryOutcomes measure: Bayley Scales of Infant and Toddler Development (BSID), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 46 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rotunda Hospital, status: RECRUITING, city: Dublin, zip: D01 P5W9, country: Ireland, contacts name: Adele Reddin, BSc/MSc, role: CONTACT, email: areddin@rotunda.ie, geoPoint lat: 53.33306, lon: -6.24889, locations facility: National Maternity Hospital, Holles Street, status: RECRUITING, city: Dublin, zip: D02 YH21, country: Ireland, contacts name: Emma Doyle, BSc/MSc, role: CONTACT, email: emma.doyle@nmh.ie, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Coombe Womens Hospital, status: RECRUITING, city: Dublin, zip: D08 XW7X, country: Ireland, contacts name: Eibhlin Cary Healy, MRCPI, role: CONTACT, email: ehealy@coombe.ie, contacts name: Mariapia Dado, BSc/MSc, role: CONTACT, phone: +35314085571, phoneExt: 4541, email: MDado@coombe.ie, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False