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Effect of Maternal Smoking On Neonatal Lung Function

Primary Purpose

Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Diseases, Obstructive

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005285
    Brief Title
    Effect of Maternal Smoking On Neonatal Lung Function
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1985 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 1996 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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 and/or 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8616555
    Citation
    David MM, Hanrahan JP, Carey V, Speizer FE, Tager IB. Respiratory symptoms in urban Hispanic and non-Hispanic white women. Am J Respir Crit Care Med. 1996 Apr;153(4 Pt 1):1285-91. doi: 10.1164/ajrccm.153.4.8616555.
    Results Reference
    background
    PubMed Identifier
    8970389
    Citation
    Weiss ST, Ware JH. Overview of issues in the longitudinal analysis of respiratory data. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 2):S208-11. doi: 10.1164/ajrccm/154.6_Pt_2.S208. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8970396
    Citation
    Rijcken B, Weiss ST. Longitudinal analyses of airway responsiveness and pulmonary function decline. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 2):S246-9. doi: 10.1164/ajrccm/154.6_Pt_2.S246. No abstract available.
    Results Reference
    background
    Citation
    Hanrahan JP, Segal MR, Chervin BS, Barr MB, VanVunakis H, Weiss ST, Speizer FE, Tager IB: Early vs. Late Prenatal Smoking: Effect on Birth Rate. Am Rev Respir Dis, 137:253, 1988
    Results Reference
    background
    Citation
    Chervin BS, Barr MB, Hanrahan JP, Segal MR, VanVunakis H, Weiss ST, Tager IB, Speizer FE: Assessment of Prenatal Infant Exposure to Maternal Smoking. Am Rev Respir Dis, 137:253, 1988
    Results Reference
    background
    Citation
    Hanrahan JP, Castile RG, Segal MR, Aylward D, Barr MB, Chervin BS, Tager IB, Speizer FE, Weiss ST: Longitudinal Lung and Airway Growth in Healthy Infants in the First 6 Months of Life. Am Rev Respir Dis, 137:381, 1988
    Results Reference
    background
    PubMed Identifier
    2339835
    Citation
    Hanrahan JP, Tager IB, Castile RG, Segal MR, Weiss ST, Speizer FE. Pulmonary function measures in healthy infants. Variability and size correction. Am Rev Respir Dis. 1990 May;141(5 Pt 1):1127-35. doi: 10.1164/ajrccm/141.5_Pt_1.1127.
    Results Reference
    background
    PubMed Identifier
    1586058
    Citation
    Hanrahan JP, Tager IB, Segal MR, Tosteson TD, Castile RG, Van Vunakis H, Weiss ST, Speizer FE. The effect of maternal smoking during pregnancy on early infant lung function. Am Rev Respir Dis. 1992 May;145(5):1129-35. doi: 10.1164/ajrccm/145.5.1129.
    Results Reference
    background
    PubMed Identifier
    8590331
    Citation
    Weiss ST. Problems in the phenotypic assessment of asthma. Clin Exp Allergy. 1995 Nov;25 Suppl 2:12-4; discussion 17-8. doi: 10.1111/j.1365-2222.1995.tb00410.x. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8545164
    Citation
    Adler A, Tager IB, Brown RW, Ngo L, Hanrahan JP. Relationship between an index of tidal flow and lower respiratory illness in the first year of life. Pediatr Pulmonol. 1995 Sep;20(3):137-44. doi: 10.1002/ppul.1950200303.
    Results Reference
    background
    PubMed Identifier
    7675554
    Citation
    Brown RW, Hanrahan JP, Castile RG, Tager IB. Effect of maternal smoking during pregnancy on passive respiratory mechanics in early infancy. Pediatr Pulmonol. 1995 Jan;19(1):23-8. doi: 10.1002/ppul.1950190105.
    Results Reference
    background
    PubMed Identifier
    8466114
    Citation
    Tager IB, Hanrahan JP, Tosteson TD, Castile RG, Brown RW, Weiss ST, Speizer FE. Lung function, pre- and post-natal smoke exposure, and wheezing in the first year of life. Am Rev Respir Dis. 1993 Apr;147(4):811-7. doi: 10.1164/ajrccm/147.4.811.
    Results Reference
    background
    PubMed Identifier
    7663813
    Citation
    Tager IB, Ngo L, Hanrahan JP. Maternal smoking during pregnancy. Effects on lung function during the first 18 months of life. Am J Respir Crit Care Med. 1995 Sep;152(3):977-83. doi: 10.1164/ajrccm.152.3.7663813.
    Results Reference
    background

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