Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005432 |
| Other study ID # |
4350 |
| Secondary ID |
R03HL054331 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
March 15, 2016 |
| Start date |
May 1995 |
| Est. completion date |
December 1997 |
Study information
| Verified date |
November 2001 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial 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)?
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 i.e. 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 Center's 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.
