Effects of Smoking on InfantNCT00563966
The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy
An observational study of Effects of Smoking on Infant, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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 children's behavioral disturbances. Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Smoking on Infant
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who smoked during pregnancy
Who may be able to join
- Smokes at least 10 cigarettes a day
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
David Mankuta, MD
Rachel Bachner, PhD
About this study
Official title: The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy: Genes, Hormones and Psychological Modulators
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 children's 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.
Read the 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 (e.g., 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' feelings/behavior 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, triple/quadra 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 (i.e., 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
- Conditions
- Effects of Smoking on Infant
- Keywords
- smoking pregnancy behaviour polymorphisms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startApr 2008
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Smoking on InfantStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- Ebstein Richard, MD PhD, Study chair, Hebrew University Jerusalem Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563966
- Sponsor's protocol ID
- smokingmothers-HMO-CTIL
- Status last verified
- Nov 2007
- First submitted
- 25 Nov 2007
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy: Genes, Hormones and Psychological Modulators
- ClinicalTrials.gov ID
- NCT00563966
- Acronym / sponsor ID
- smokingmothers-HMO-CTIL
- Conditions
- Effects of Smoking on Infant
- Keywords
- smoking pregnancy behaviour polymorphisms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Apr 2008
- Study completion
- Dec 2008 (estimated)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 children's 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.
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 (e.g., 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' feelings/behavior 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, triple/quadra 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 (i.e., 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 design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who smoked during pregnancy
Key inclusion criteria (7 listed)
- Smokes at least 10 cigarettes a day
- No abuse of alcohol or drugs
- No chronic physical disability
- 22-35 years of age
- Living with partner
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
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Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Asthma, Pulmonary Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebstein Richard, MD PhD study chair
Hebrew University Jerusalem Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of Smoking on Infant, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Mankuta, MD (97226776484, mankutad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2008.