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Premature Birth and Its Sequelae in Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005376
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To establish in children born prematurely a set of links between lung function in late infancy and lung function at school age, between lung function at school age and that in adolescence, and between lung function in adolescence and that in adulthood in order to evaluate pulmonary outcomes of neonatal therapeutic strategies and to relate these strategies to lung health in adult life.

Condition
Bronchopulmonary Dysplasia Lung Diseases

Study Type: Observational

Resource links provided by NLM:


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

Study Start Date: September 1993
Study Completion Date: August 1998
Detailed Description:

BACKGROUND:

Effective perinatal treatment strategies during the past 20 years have increased the survival of low birth weight infants. Accompanying this increased survival has been a 4-6 fold increase in the number of children surviving with bronchopulmonary dysplasia, although the birthweight specific incidence has remained constant or declined. Limited data currently available indicate that individuals who had BPD as infants have, as childrearing adults, impaired lung growth as well as both fixed and reversible airways obstruction.

The study was part of an Institute-initiated program on Collaborative Projects in Women's Health. The concept was developed by the NHLBI staff and given concept clearance at the February 1992 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in April 1992.

DESIGN NARRATIVE:

The study was part of a four-grant collaborative project on women's health. Based on available data, Dr. Mary Ellen Wohl hypothesized that bronchopulmonary dysplasia (BPD) morbidity was related to impaired lung growth in the first year of life, did not improve during adolescence and was accentuated in females because of their intrinsically smaller lungs. To test this hypothesis, she measured lung size and airway function in teenagers and young adults, previously studied at school age, who were born, 1) at term, 2) prematurely, 3) developed respiratory distress syndrome of the newborn (RDS) or 4) developed BPD. Children born from 1987-89 previously studied at 10 months of age by novel lung function function methods developed in this laboratory were restudied at school age. Techniques of measuring total respiratory system compliance and resistance and of obtaining forced expiratory flow at functional residual capacity were applied to cohorts of born premature infants at 10-18 months of age to assess outcome of current perinatal strategies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00005376     History of Changes
Other Study ID Numbers: 4273
R01HL050844 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
Last Verified: November 2001

Additional relevant MeSH terms:
Lung Diseases
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases