Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005285
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Effect of Maternal Smoking On Neonatal Lung Function
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-04
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:
None
Brief Summary:
To determine factors including maternal cigarette smoking and acute respiratory illness influencing infant lung function at birth and up to five years of age
Detailed Description:
BACKGROUND
Over the past four decades a significant research effort has been devoted to the understanding of the epidemiology and pathophysiology of chronic obstructive airways disease COPD in adult life Epidemiologic studies uniformly have identified cigarette smoking as the predominant risk factor for the occurrence of COPD Other factors such as socioeconomic status environmental pollution occupational exposures and inherent genetic susceptibility have been observed to have very limited roles as risk factors
A number of studies have suggested that postnatal maternal cigarette smoking has a measurable effect on lung function in children One longitudinal analysis of this problem in children 5-19 years of ages identified significant effects on the growth of FEV1 and forced expiratory flow between the 25th and 75th percent volume points FEF25-75 of the volume-time curve These investigators however pointed out that the effects which they observed could have resulted from the in utero consequences of maternal smoking during pregnancy andor from exposure to factors such as severe respiratory illnesses which have been documented to occur with increased frequency early in infancy and were not measured by the study
DESIGN NARRATIVE
Pregnant women were identified during the first trimester and followed monthly Assessments were made of their smoking habits urinary cotinine measurements general medical condition and status of pregnancy Within two weeks of birth the infants were evaluated with partial forced expiratory flow-volume curves and measurement of passive respiratory system compliance and resistance Measurements were repeated at intervals until age five Babies were also observed regularly for respiratory illness experience passive exposure to cigarette smoke and general respiratory health
The study helped to elucidate the effect of maternal cigarette smoking on lung function at birth and development of function at five years the effects of postnatal factors on lung development the extent to which the reported increased frequency of respiratory illness in infants of smoking mothers resulted from in utero exposure to tobacco smoke products or postnatal passive smoking
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Over the past four decades a significant research effort has been devoted to the understanding of the epidemiology and pathophysiology of chronic obstructive airways disease COPD in adult life Epidemiologic studies uniformly have identified cigarette smoking as the predominant risk factor for the occurrence of COPD Other factors such as socioeconomic status environmental pollution occupational exposures and inherent genetic susceptibility have been observed to have very limited roles as risk factors
A number of studies have suggested that postnatal maternal cigarette smoking has a measurable effect on lung function in children One longitudinal analysis of this problem in children 5-19 years of ages identified significant effects on the growth of FEV1 and forced expiratory flow between the 25th and 75th percent volume points FEF25-75 of the volume-time curve These investigators however pointed out that the effects which they observed could have resulted from the in utero consequences of maternal smoking during pregnancy andor from exposure to factors such as severe respiratory illnesses which have been documented to occur with increased frequency early in infancy and were not measured by the study
DESIGN NARRATIVE
Pregnant women were identified during the first trimester and followed monthly Assessments were made of their smoking habits urinary cotinine measurements general medical condition and status of pregnancy Within two weeks of birth the infants were evaluated with partial forced expiratory flow-volume curves and measurement of passive respiratory system compliance and resistance Measurements were repeated at intervals until age five Babies were also observed regularly for respiratory illness experience passive exposure to cigarette smoke and general respiratory health
The study helped to elucidate the effect of maternal cigarette smoking on lung function at birth and development of function at five years the effects of postnatal factors on lung development the extent to which the reported increased frequency of respiratory illness in infants of smoking mothers resulted from in utero exposure to tobacco smoke products or postnatal passive smoking
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL036474 | NIH | None | httpsreporternihgovquickSearchR01HL036474 |