Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005376
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Premature Birth and Its Sequelae in Women
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:
2001-11
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 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
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 Womens 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 womens 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
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 Womens 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 womens 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 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 |
|---|---|---|---|
| R01HL050844 | NIH | None | httpsreporternihgovquickSearchR01HL050844 |