Pregnancy Related Clinical Trial
— ECHOOfficial title:
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes (ECHO) Study.
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.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 46 Years |
Eligibility | Inclusion Criteria: - Women aged 18 or greater and less than 46 years of age at booking - Pregnant with a singleton fetus - Smokers (exhaled CO reading of greater than or equal to 4) or - Self-reported vaper or - Dual user (smoker/vaper) - Non-smokers - Able to understand and read English. - Willing to agree to follow-up for the two-year duration of the study in the postnatal period (ie. unlikely to move out of the catchment area). Exclusion Criteria: - Women pregnant with twins or higher order multiples - Late bookers - defined as booking after 24+0 weeks' gestational age - Fetus or infant diagnosed with a major congenital abnormality (major structural abnormality, ie congenital diaphragmatic hernia (CDH), omphalocele, major cardiac defects ie. which require immediate admission to NICU +/- transfer to cardiology for surgery, chromosomal abnormalities, syndromes - Turner's/Noonan's) or a lethal fetal anomaly - Any inherited disorder of metabolism or Cystic Fibrosis on Guthrie Card/ neonatal blood spot screening - History of significant medical disorder in pregnancy e.g. cardiac, haematological, or endocrine disease (including gestational diabetes requiring insulin) - Significant maternal psychiatric disorder, e.g. delusional or psychotic disorders, severe depression requiring hospitalisation, use of >1 psychotropic drugs for treatment - Serious co-morbid addiction issues e.g. opiate abuse, methadone maintenance program - Severe intellectual disability or lack of capacity |
Country | Name | City | State |
---|---|---|---|
Ireland | Coombe Womens Hospital | Dublin | |
Ireland | National Maternity Hospital, Holles Street | Dublin | |
Ireland | Rotunda Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin | Royal College of Surgeons, Ireland |
Ireland,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of preterm birth | Obstetric | Up to the time of birth | |
Primary | Incidence of low birth weight | Neonatal: Defined as less than the 10th centile | Up to the time of birth | |
Primary | Incidence of wheeze during the first two years of life | Paediatric | 6, 12 and 24 months | |
Secondary | Incidence of smoking and vaping | Obstetric and paediatric | Through study completion, up to 24 months | |
Secondary | Estimated foetal weight | Obstetric | 20 and 34 weeks gestation | |
Secondary | Trends in carbon monoxide levels | Obstetric | Antenatal: At time of recruitment, 20 weeks, 34 weeks; postnatally: birth, 12 and 24 months | |
Secondary | Blood pressure measurements (both diastolic and systolic) | Obstetric | At time of recruitment, 20 weeks, 34 weeks | |
Secondary | Urine cotinine measurements | Obstetric | At time of recruitment, 20 weeks, 34 weeks and delivery | |
Secondary | Incidence of maternal cough, wheeze and/or asthma | Obstetric | At time of recruitment, 20 weeks, 34 weeks and birth | |
Secondary | Maternal history of abnormal cervical screening cytology | Obstetric | At time of recruitment | |
Secondary | Incidence of pre-eclampsia and/or hypertension during pregnancy | Obstetric | At time of recruitment, 20 weeks, 34 weeks and delivery | |
Secondary | Incidence of birth complications | Obstetric | At the time of birth | |
Secondary | Edinburgh postnatal depression score | Maternal neuropsychology (Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder.) | At the time of birth | |
Secondary | APGAR scores at 1, 5 and 10 minutes after birth | Neonatal - APGAR: Appearance, Pulse, Grimace, Activity, Respiratory. Scores are between 0 and 10, with score above 7 normal. | At the time of birth | |
Secondary | Admission to neonatal intensive care | Neonatal | At the time of birth | |
Secondary | Incidence of neonatal complications | Neonatal | At the time of birth | |
Secondary | Neonatal and paediatric anthropometric measurements over first two years of life | Neonatal and paediatric - (Weight, height, body mass index, head circumference, waist circumference, chest circumference and mid-arm circumference measurements) | At the time of birth, 12 and 24 months | |
Secondary | Neonatal body composition measurements | Neonatal - using a PEA POD machine, we will measure measure body volume using air displacement plethysmography. | At the time of birth | |
Secondary | Incidence of respiratory illnesses | Paediatric | 6,12 and 24 months | |
Secondary | Number of attendances/admissions to hospital | Paediatric | 6,12 and 24 months | |
Secondary | Frequency of prescribed respiratory medications use | Paediatric | 6, 12 and 24 months | |
Secondary | Barkely Functional Impairment score (BFIS) | Maternal neuropsychology - The BFIS is designed to evaluate possible impairment in 15 major domains of psychosocial functioning in adults. The score is between 0-10, 10 being indicative of increased functional impairment. | At the time of birth | |
Secondary | Early Executive Functions Questionnaire (EEFQ) | Paediatric neuropsychology -The 31-item EEFQ parent report measure complements temperament measures by targeting cognitive and regulatory capabilities. Each question is scored between 1(never) and 7(always) to measure executive function in babies. | 12 and 24 months | |
Secondary | Infant Behaviour Questionnaire (IBQ) | Paediatric neuropsychology - The 37 item parent report measure of infant temperament. Each item is scored between 1 (never) and 7 (always to measure infant temperament. | 12 months | |
Secondary | Child Behaviour Checklist (CBCL) | Paediatric neuropsychology - The 113-item CBCL is a parent report measure designed to assess behavioural and emotional problems in children. The CBCL is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). | 24 months | |
Secondary | Early Childhood Behaviour Questionnaire (ECBQ) | Paediatric neuropsychology - The ECBQ is a parent reported measure of a child's temperament. The ECBQ contains 36 items with 7 broad likert scales from which a score is calculated. The higher the likert scale, the better the score. | 24 months | |
Secondary | Bayley Scales of Infant and Toddler Development (BSID) | Paediatric neuropsychology - The Bayley Scale is an extensive formal developmental assessment tool for diagnosing developmental delays in early childhood. The BSID measures scores in the five domains of cognition, language (receptive and expressive language abilities), motor skills (fine and gross motor skills), socio-emotional behaviour and adaptive behaviour. The BSID index scores within a range of 40-160. The higher score indicating normal development. | 12 months |
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