- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005376
Premature Birth and Its Sequelae in Women
Study Overview
Status
Conditions
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4273
- R01HL050844 (U.S. NIH Grant/Contract)
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