Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297005
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-16
Brief Title:
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study
Sponsor:
University College Dublin
Organization:
University College Dublin
Study Overview
Official Title:
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes ECHO Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHO
Brief Summary:
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
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
Detailed Description:
Background Much is already known about the negative health effects of tobacco smoking during pregnancy There is no national data on smoking in pregnancy but research indicates that up to 10 of Irish women continue to smoke tobacco in pregnancy Tobacco smoking is associated with significant obstetric and perinatal complications including preterm birth premature rupture of membranes placental abruption placenta previa and intrauterine growth restriction and stillbirth Tobacco smoking is associated with a higher incidence of congenital abnormalities Infants born to smoking mothers are at increased risk of necrotizing enterocolitis in the neonatal period and of sudden infant death syndrome SIDS Children of smokers have an increased prevalence of wheeze and asthma There is emerging evidence of cognitive impairment with higher rates of abnormal behavioural and neurodevelopmental outcomes such as attention deficit hyperactivity disorder ADHD and poor academic performance in the off-spring of mothers who smoke in pregnancy
The popularity of electronic nicotine delivery systems ENDS has risen significantly over the past 10 years particularly among young adults and adolescents ENDS also called e-cigarettes or vaping devices are battery powered devices that heat a solution e-liquid to create an aerosol that contains nicotine In addition to nicotine the e-liquid often contains different flavourings as well as the compounds Propylene Glycol and Glycerin The vapour created by heating e-liquid at high temperatures alters the chemical profile of the original liquid by producing hazardous compounds such as aldehydes More than 15000 different flavours have been reported to date ENDS aerosols contain fewer harmful substances when compared with tobacco smoking As a result they have been proposed as a safer alternative to tobacco smoking Much research on these devices currently focuses on their role as a tobacco cessation tool Currently there is insufficient evidence to determine if ENDS are a safe and effective long-term tobacco cessation method However there is emerging evidence that are not harmless products and that they contain toxic compounds which have hazardous effects on different organs in the body to users
Research on the long-term health effects of ENDS particularly from animal studies suggests that there are negative growth cardiopulmonary and neurological physiological changes caused by ENDS Animal models have demonstrated that chronic exposure to ENDS results in increased arterial stiffness vascular endothelial changes increased angiogenesis and atherosclerotic plaque formation Pulmonary changes including increased airway hyperreactivity airway obstruction inflammation and emphysematous changes have all been documented in animal studies on ENDS Neurotoxic effects reported in mice studies include calcium dyshomeostasis epigentic changes impaired autophagy and neurotransmission oxidate stress mitochondrial dysfunction and neuroinflammation As nicotine the primary ingredient in ENDS easily crosses the placental barrier these harmful effects have the potential to impact the unborn foetus of pregnant women who use ENDS
There is a paucity of real world data on the fetal and neonatal effects of ENDS use during pregnancy A few studies which have examined obstetric and birth outcomes in women using e-cigarettes during pregnancy with mixed results An Irish study of over 400 pregnant women reported that birth weight and neonatal outcomes were similar in women who were sole users of e-cigarettes when compared with non-smokers However two other studies did demonstrate an association between exclusive e-cigarette use during pregnancy and low birth weight and preterm delivery These are important predictors of adverse outcomes in the neonatal period The proposed study will help to clarify any association between ENDS use preterm birth and fetal growth restriction
The SNAP trial was a randomised control trial examining the effectiveness of nicotine replacement therapy NRT versus placebo on smoking cessation in pregnant women who smoked The study also examined clinical outcomes at two years of age and found that children born to women on the NRT arm of the study had no adverse outcomes at two years of age While NRT is generally considered a much safer option for pregnant women looking to quit smoking ENDS are not currently recommended as a smoking cessation tool in Ireland or in most countries in the world The use of ENDS among pregnant women has risen over the past decade The exact prevalence of ENDS use is unknown but a number of studies across the world report this figure to be between 1-15 A more recent systematic review from the US reported a prevalence of 12-7 whereas the prevalence rate was 28 in a survey of over 4000 pregnant women in the UK
According to the Healthy Ireland survey 2019 the current rate of ENDS use in Ireland is 5 and a further 12 have tried them at some point Of those smokers who have made a quit attempt 38 used ENDS From an Irish perspective we have very little data on the use of ENDS during pregnancy A recent study from the Coombe Women Infants University Hospital identified 449 pregnant ENDS over a period of 13 months 8500 deliveries per year We expect that a similar number of ENDS users could be recruited at the other two Dublin maternity hospitals
Knowledge gap At present there is insufficient evidence on the clinical impact of prenatal exposure to ENDS on children The hypotheses reported in animal studies need to be tested in longitudinal studies in humans Real world studies are clearly needed to examine the impact of prenatal exposure of ENDS in childhood and beyond
Research questions What are the nutritional pulmonary and neuro-behavioural consequences for young children born to mothers using ENDS during pregnancy
The specific research questions are -
Do infants exposed to ENDS in utero have a lower birthweight compared with infants of non-smokers
Are children exposed to ENDS in utero at a higher risk of wheezeasthma at two years of age compared with children of non-smokers
Do children exposed to ENDS in utero have impaired neurocognitive functioning at the age of two years compared with children of non-smokers
Are these outcomes measures different between children exposed to ENDS in utero compared with children exposed to tobacco smoke in utero
Aims and objectives The aim of the ECHO study is to examine obstetric growth pulmonary and neuro-behavioural outcomes over the first two years of life in children exposed to ENDS in utero and compare them with children born to pregnant women who are either tobacco smokers or non-smokers
The objectives of the study are -
To establish whether infants born to mothers who are ENDS users are at a higher risk of preterm birth compared with non-smokers but lower risk compared with smokers
To establish whether there are significant differences in growth between children of women who use tobacco or ENDS and children of non-smokers
To establish whether parent reported and doctor confirmed wheeze andor asthma occurs more frequently in children exposed to ENDS in utero compared with children of non-smokers and less frequently compared with children of tobacco smokers
To establish whether there are differences in healthcare utilisation between children exposed to tobacco smoking or ENDS in utero and children of non-smokers
To establish whether there are significant differences in neurocognitive outcomes between children of women who use ENDS women who smoke tobacco and children of non-smokers
The popularity of electronic nicotine delivery systems ENDS has risen significantly over the past 10 years particularly among young adults and adolescents ENDS also called e-cigarettes or vaping devices are battery powered devices that heat a solution e-liquid to create an aerosol that contains nicotine In addition to nicotine the e-liquid often contains different flavourings as well as the compounds Propylene Glycol and Glycerin The vapour created by heating e-liquid at high temperatures alters the chemical profile of the original liquid by producing hazardous compounds such as aldehydes More than 15000 different flavours have been reported to date ENDS aerosols contain fewer harmful substances when compared with tobacco smoking As a result they have been proposed as a safer alternative to tobacco smoking Much research on these devices currently focuses on their role as a tobacco cessation tool Currently there is insufficient evidence to determine if ENDS are a safe and effective long-term tobacco cessation method However there is emerging evidence that are not harmless products and that they contain toxic compounds which have hazardous effects on different organs in the body to users
Research on the long-term health effects of ENDS particularly from animal studies suggests that there are negative growth cardiopulmonary and neurological physiological changes caused by ENDS Animal models have demonstrated that chronic exposure to ENDS results in increased arterial stiffness vascular endothelial changes increased angiogenesis and atherosclerotic plaque formation Pulmonary changes including increased airway hyperreactivity airway obstruction inflammation and emphysematous changes have all been documented in animal studies on ENDS Neurotoxic effects reported in mice studies include calcium dyshomeostasis epigentic changes impaired autophagy and neurotransmission oxidate stress mitochondrial dysfunction and neuroinflammation As nicotine the primary ingredient in ENDS easily crosses the placental barrier these harmful effects have the potential to impact the unborn foetus of pregnant women who use ENDS
There is a paucity of real world data on the fetal and neonatal effects of ENDS use during pregnancy A few studies which have examined obstetric and birth outcomes in women using e-cigarettes during pregnancy with mixed results An Irish study of over 400 pregnant women reported that birth weight and neonatal outcomes were similar in women who were sole users of e-cigarettes when compared with non-smokers However two other studies did demonstrate an association between exclusive e-cigarette use during pregnancy and low birth weight and preterm delivery These are important predictors of adverse outcomes in the neonatal period The proposed study will help to clarify any association between ENDS use preterm birth and fetal growth restriction
The SNAP trial was a randomised control trial examining the effectiveness of nicotine replacement therapy NRT versus placebo on smoking cessation in pregnant women who smoked The study also examined clinical outcomes at two years of age and found that children born to women on the NRT arm of the study had no adverse outcomes at two years of age While NRT is generally considered a much safer option for pregnant women looking to quit smoking ENDS are not currently recommended as a smoking cessation tool in Ireland or in most countries in the world The use of ENDS among pregnant women has risen over the past decade The exact prevalence of ENDS use is unknown but a number of studies across the world report this figure to be between 1-15 A more recent systematic review from the US reported a prevalence of 12-7 whereas the prevalence rate was 28 in a survey of over 4000 pregnant women in the UK
According to the Healthy Ireland survey 2019 the current rate of ENDS use in Ireland is 5 and a further 12 have tried them at some point Of those smokers who have made a quit attempt 38 used ENDS From an Irish perspective we have very little data on the use of ENDS during pregnancy A recent study from the Coombe Women Infants University Hospital identified 449 pregnant ENDS over a period of 13 months 8500 deliveries per year We expect that a similar number of ENDS users could be recruited at the other two Dublin maternity hospitals
Knowledge gap At present there is insufficient evidence on the clinical impact of prenatal exposure to ENDS on children The hypotheses reported in animal studies need to be tested in longitudinal studies in humans Real world studies are clearly needed to examine the impact of prenatal exposure of ENDS in childhood and beyond
Research questions What are the nutritional pulmonary and neuro-behavioural consequences for young children born to mothers using ENDS during pregnancy
The specific research questions are -
Do infants exposed to ENDS in utero have a lower birthweight compared with infants of non-smokers
Are children exposed to ENDS in utero at a higher risk of wheezeasthma at two years of age compared with children of non-smokers
Do children exposed to ENDS in utero have impaired neurocognitive functioning at the age of two years compared with children of non-smokers
Are these outcomes measures different between children exposed to ENDS in utero compared with children exposed to tobacco smoke in utero
Aims and objectives The aim of the ECHO study is to examine obstetric growth pulmonary and neuro-behavioural outcomes over the first two years of life in children exposed to ENDS in utero and compare them with children born to pregnant women who are either tobacco smokers or non-smokers
The objectives of the study are -
To establish whether infants born to mothers who are ENDS users are at a higher risk of preterm birth compared with non-smokers but lower risk compared with smokers
To establish whether there are significant differences in growth between children of women who use tobacco or ENDS and children of non-smokers
To establish whether parent reported and doctor confirmed wheeze andor asthma occurs more frequently in children exposed to ENDS in utero compared with children of non-smokers and less frequently compared with children of tobacco smokers
To establish whether there are differences in healthcare utilisation between children exposed to tobacco smoking or ENDS in utero and children of non-smokers
To establish whether there are significant differences in neurocognitive outcomes between children of women who use ENDS women who smoke tobacco and children of non-smokers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None