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Effect of Maternal Smoking On Neonatal Lung Function

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005285
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: April 2001
  Purpose

To determine factors, including maternal cigarette smoking and acute respiratory illness, influencing infant lung function at birth and up to five years of age.


Condition
Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1985
Estimated Study Completion Date: November 1996
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
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
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
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

ClinicalTrials.gov Identifier: NCT00005285     History of Changes
Other Study ID Numbers: 2006
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014