Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005432
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Impact of Surfactants Availability on Newborns
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 identify what happened to specific groups of newborns after surfactant was introduced to the market Were the same benefits with regard to morbidity mortality and resource use in evidence post treatment investigational new drug IND
Detailed Description:
BACKGROUND
The clinical trial literature on surfactant clearly demonstrated that surfactant therapy resulted in improved early respiratory status and improved mortality rates for premature newborns infants suffering from respiratory ailments due to surfactant insufficiency However the clinical trial experience regarding efficacy did not ensure that the same benefits would be conferred on patients outside the clinical trial environment during routine medical care
DESIGN NARRATIVE
The investigators had already demonstrated in an epidemiological study published in the New England Journal of Medicine May 1994 that morbidity mortality and resource use among very low birth weight inborn infants declined once surfactant became available This study broadened the focus to include infants excluded from the original study The hypotheses for the study centered on the investigators belief that infants who were in the 1500 to 2500 gram weight group also experienced reduced mortality morbidity and resource use post-surfactant as did those who were mature with severe respiratory disease and those who were outborn ie those who were transferred to a perinatal center Finally because of the significant focus on health care reform and quality assurance in clinical care the investigators included a hypothesis focusing on the impact of payer on mortality morbidity and resource use The original study identified that the payer was not a factor differentiating the newborns with regard to any measures of outcome or resource use The investigators hypothesized that this would remain the case However they suspected that there might be some indications in their analysis among patients who were outborn that HMO or managed care was influencing not only where births were occurring but how well fragile newborns did in the clinical environment All the analyses used analytic datafiles from the National Perinatal Information Centers Perinatal Center Database A pre-and post-surfactant period was created using eleven perinatal centers who provided data on all newborns from 1985 and 1992 Infants were divided into two groups according to whether they were born before or after surfactant was introduced into clinical practice Regression models controlling for race sex and birthweight were used to assess morbidity mortality and resource use
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The clinical trial literature on surfactant clearly demonstrated that surfactant therapy resulted in improved early respiratory status and improved mortality rates for premature newborns infants suffering from respiratory ailments due to surfactant insufficiency However the clinical trial experience regarding efficacy did not ensure that the same benefits would be conferred on patients outside the clinical trial environment during routine medical care
DESIGN NARRATIVE
The investigators had already demonstrated in an epidemiological study published in the New England Journal of Medicine May 1994 that morbidity mortality and resource use among very low birth weight inborn infants declined once surfactant became available This study broadened the focus to include infants excluded from the original study The hypotheses for the study centered on the investigators belief that infants who were in the 1500 to 2500 gram weight group also experienced reduced mortality morbidity and resource use post-surfactant as did those who were mature with severe respiratory disease and those who were outborn ie those who were transferred to a perinatal center Finally because of the significant focus on health care reform and quality assurance in clinical care the investigators included a hypothesis focusing on the impact of payer on mortality morbidity and resource use The original study identified that the payer was not a factor differentiating the newborns with regard to any measures of outcome or resource use The investigators hypothesized that this would remain the case However they suspected that there might be some indications in their analysis among patients who were outborn that HMO or managed care was influencing not only where births were occurring but how well fragile newborns did in the clinical environment All the analyses used analytic datafiles from the National Perinatal Information Centers Perinatal Center Database A pre-and post-surfactant period was created using eleven perinatal centers who provided data on all newborns from 1985 and 1992 Infants were divided into two groups according to whether they were born before or after surfactant was introduced into clinical practice Regression models controlling for race sex and birthweight were used to assess morbidity mortality and resource use
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 |
|---|---|---|---|
| R03HL054331 | NIH | None | httpsreporternihgovquickSearchR03HL054331 |