Ignite Creation Date:
2024-05-05 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00563966
Status:
UNKNOWN
Last Update Posted:
2008-05-12
First Post:
2007-11-25
Brief Title:
The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy Genes Hormones and Psychological Modulators
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
RECRUITING
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:
None
Brief Summary:
It is generally understood that smoking during pregnancy has deleterious effects on the developing fetus although research on smoking during pregnancy has been limited in focus with most studies focused on birth weight of newborns and childrens behavioral disturbances However little is known about the neurobiological underpinnings of nicotine-related developmental deficits and even less is known about genetic and environmental factors that may exacerbate the risk for such deficits in some children In this study we propose to examine the relation between antenatal exposure to nicotine and infants stress-responses before and after birth 2-days 6-months and its moderation of by family-based stressors and genes related to nicotine metabolism and stress responsivity
We hypothesize that the risk imposed on infants by antenatal exposure to nicotine is moderated by genotype that influences functioning of the HPA axis metabolism of nicotine and stress-levels and parenting that influence the development of neural substrates HPA axis and infants capacity to cope with stress There is a growing consensus that Gene x Environmental G x E interplay likely mediated by epigenetic effects constitute one of the central mechanism by which complex disorders develop Our proposal offers an exceptional paradigm to explore the association between genes environment and G x E interactions on the neural and behavior response of children to stressful challenges
We hypothesize that the risk imposed on infants by antenatal exposure to nicotine is moderated by genotype that influences functioning of the HPA axis metabolism of nicotine and stress-levels and parenting that influence the development of neural substrates HPA axis and infants capacity to cope with stress There is a growing consensus that Gene x Environmental G x E interplay likely mediated by epigenetic effects constitute one of the central mechanism by which complex disorders develop Our proposal offers an exceptional paradigm to explore the association between genes environment and G x E interactions on the neural and behavior response of children to stressful challenges
Detailed Description:
Detailed Description of the Proposed Research
Design overview A large cohort of pregnant women will be recruited and those who meet criteria will be divided into two groups according to their testimony regarding their smoking behavior and saliva cotinine screening as in our previous studies At 3-time points the antenatal period 2-days and 6-months of age we will assess infants responses to challenges using biochemical behavioral and subjective measures The challenges selected are proven stressors and previous research has demonstrated their effectiveness in eliciting stress-reactions eg increased cortisol In parallel we will obtain an obstetric history from medical records demographics measure of symptomology information on smoking and drinking habits life stresses and family cohesion at each time point plus information about mothers feelingsbehavior and mothers ratings of infants regulatory behavior after birth The antenatal and neonatal sessions will be carried out in Hadassah Hospital and the 6-month session in the developmental laboratory at Hebrew University Genetic material will be collected from parents and their infant at childbirth
Recruitment Women smokers will be recruited will be recruited by nurses in well-baby clinics where physicians do routine prenatal check-ups gynecologists midwives and by advertisement In addition we will recruit women at the time of routine checks in Hadassah hospital Nuchal translucency test at 12 weeks triplequadra test blood testing at 16 weeks early 14-16 weeks and advanced 20-22 week fetal anatomy scan and glucose test at 24-28 weeks supervised by Dr Mankuta In all we will recruit 150 women for the smoking group using the following inclusion criteria smokes at least 10 cigarettes a day ie habitual smokers no abuse of alcohol or drugs no chronic physical disability 22-35 years of age living with partner speaks English Hebrew or Russian natural conception A second group of 150 women who meet inclusion criteria except smoking and matched in age education gender of infant and parity to the smokers will serve as controls At recruitment and each time-point mothers and their spouses who agree to participate in the research protocol will be interviewed for smoking habits Fagerstrom Tolerance Questionnaire FTQ as detailed in our previous studies on smoking At recruitment women will be explicitly told that we are not encouraging smoking and will provide resources if at any time during the study they want to stop smoking
Antenatal period Dr David Mankuta
The prenatal session will be carried out at 34-36 weeks of gestation by last menstrual period and confirmed by early ultrasound and will consist of 3 phases 1 waiting room- in which mothers receive instructions 2 ultrasound- to evaluate limb movement before and after vibroacoustic stimulation VAS as well as measures of fetuses well-being cardiotocograph test biophysical profile and 3 post exam- administration of questionnaires
Limb movement Measures of fetal limb movement are good reflections of infant state are stable from late gestation out to 4-weeks postnatal age 80 are affected by antenatal stress 81 and forecast infants state regulation 2 weeks after birth Ultrasound ATL 3500 and 5000 will be used to visualize and film the fetus for offline coding of limb movements To begin testing infant must be in state 1F characterized by minimal fetal movement for 2 minutes When this criterion is met baseline the VAS Fetal Acoustic Corometrics Stimulator Model 146 75 HZ 82 db will be presented for 5 s Fetal movements will be videotaped with the recorder built into the scanner During off-line time-event coding each limb movement will be counted From these raw counts we will average the number of movements observed in 10 s intervals during the 1 min prior to baseline and during the 5 min after stimulation Reactivity will be derived by calculating the difference between the mean baseline count and the mean count recorded during the 5 s of stimulation Regulation will be calculated as 1 the slope of the counts across the post stimulation period 5 minutes and 2 the difference between the mean baseline count and the mean count of last three 10 second epochs for first time point Previous studies have shown limb-counts to be stable 24-36 weeks reliable and sensitive to maternal stress
Questionnaires
Design overview A large cohort of pregnant women will be recruited and those who meet criteria will be divided into two groups according to their testimony regarding their smoking behavior and saliva cotinine screening as in our previous studies At 3-time points the antenatal period 2-days and 6-months of age we will assess infants responses to challenges using biochemical behavioral and subjective measures The challenges selected are proven stressors and previous research has demonstrated their effectiveness in eliciting stress-reactions eg increased cortisol In parallel we will obtain an obstetric history from medical records demographics measure of symptomology information on smoking and drinking habits life stresses and family cohesion at each time point plus information about mothers feelingsbehavior and mothers ratings of infants regulatory behavior after birth The antenatal and neonatal sessions will be carried out in Hadassah Hospital and the 6-month session in the developmental laboratory at Hebrew University Genetic material will be collected from parents and their infant at childbirth
Recruitment Women smokers will be recruited will be recruited by nurses in well-baby clinics where physicians do routine prenatal check-ups gynecologists midwives and by advertisement In addition we will recruit women at the time of routine checks in Hadassah hospital Nuchal translucency test at 12 weeks triplequadra test blood testing at 16 weeks early 14-16 weeks and advanced 20-22 week fetal anatomy scan and glucose test at 24-28 weeks supervised by Dr Mankuta In all we will recruit 150 women for the smoking group using the following inclusion criteria smokes at least 10 cigarettes a day ie habitual smokers no abuse of alcohol or drugs no chronic physical disability 22-35 years of age living with partner speaks English Hebrew or Russian natural conception A second group of 150 women who meet inclusion criteria except smoking and matched in age education gender of infant and parity to the smokers will serve as controls At recruitment and each time-point mothers and their spouses who agree to participate in the research protocol will be interviewed for smoking habits Fagerstrom Tolerance Questionnaire FTQ as detailed in our previous studies on smoking At recruitment women will be explicitly told that we are not encouraging smoking and will provide resources if at any time during the study they want to stop smoking
Antenatal period Dr David Mankuta
The prenatal session will be carried out at 34-36 weeks of gestation by last menstrual period and confirmed by early ultrasound and will consist of 3 phases 1 waiting room- in which mothers receive instructions 2 ultrasound- to evaluate limb movement before and after vibroacoustic stimulation VAS as well as measures of fetuses well-being cardiotocograph test biophysical profile and 3 post exam- administration of questionnaires
Limb movement Measures of fetal limb movement are good reflections of infant state are stable from late gestation out to 4-weeks postnatal age 80 are affected by antenatal stress 81 and forecast infants state regulation 2 weeks after birth Ultrasound ATL 3500 and 5000 will be used to visualize and film the fetus for offline coding of limb movements To begin testing infant must be in state 1F characterized by minimal fetal movement for 2 minutes When this criterion is met baseline the VAS Fetal Acoustic Corometrics Stimulator Model 146 75 HZ 82 db will be presented for 5 s Fetal movements will be videotaped with the recorder built into the scanner During off-line time-event coding each limb movement will be counted From these raw counts we will average the number of movements observed in 10 s intervals during the 1 min prior to baseline and during the 5 min after stimulation Reactivity will be derived by calculating the difference between the mean baseline count and the mean count recorded during the 5 s of stimulation Regulation will be calculated as 1 the slope of the counts across the post stimulation period 5 minutes and 2 the difference between the mean baseline count and the mean count of last three 10 second epochs for first time point Previous studies have shown limb-counts to be stable 24-36 weeks reliable and sensitive to maternal stress
Questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None